ACRP CERTIFIED

PROFESSIONAL

Certification
Handbook
acrpnet.org
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Table of Contents
APPLYING FOR CERTIFICATION ..........................................................................................................................3
Welcome and Congratulations ................................................................................................................. 3
ACRP Certification Overview ..................................................................................................................... 3
Application Deadline ................................................................................................................................. 3
Confidentiality ........................................................................................................................................... 3
Application Process and Requirements .................................................................................................... 4
Professional Level Experience Requirements ........................................................................................... 4
ACRP-CP Eligibility Requirements ............................................................................................................. 4
Substitution for Work Experience Requirements ..................................................................................... 5
Clinical Research Certifications (Option 1) ............................................................................................... 5
Application and Exam Fees ....................................................................................................................... 5
Application for Certification ...................................................................................................................... 6
Services for People with Disabilities ......................................................................................................... 6
Submitting the Application ....................................................................................................................... 6
Receipt of Application ............................................................................................................................... 7
THE ELIGIBILITY REVIEW PROCESS ..................................................................................................................7
Eligibility Review ....................................................................................................................................... 7
Eligibility Reviewers .................................................................................................................................. 7
Confirmation of Eligibility ......................................................................................................................... 7
ACRP-CP EXAMINATION INFORMATION ..........................................................................................................8
Exam Structure.......................................................................................................................................... 8
Exam Delivery............................................................................................................................................ 8
Language ................................................................................................................................................... 8
Exam Administration................................................................................................................................. 8
Examination Window ................................................................................................................................ 9
Exam Appointment Scheduling ................................................................................................................. 9
Confirmation Number ............................................................................................................................... 9
Confirming Your Appointment .................................................................................................................. 9
Rescheduling Your Appointment............................................................................................................... 9
Cancellations, No Shows, Re-Examination, Refunds and Transfers.......................................................... 9
Preparing for the Exam ........................................................................................................................... 12
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What’s Covered on the Exam? ................................................................................................................ 12

Detailed Content Outline ........................................................................................................................ 12
Preparation Support ............................................................................................................................... 12
Taking the Exam ...................................................................................................................................... 13
Exam Appointment Arrival ...................................................................................................................... 13
Required Identification ........................................................................................................................... 13
Exam Security and Test Center Guidelines ............................................................................................. 13
Resources Available at the Test Center .................................................................................................. 14
Exam Scores ............................................................................................................................................ 14
Exam Results and Notification ................................................................................................................ 14
Appendix – CP Detailed Content Outline (DCO) ..................................................................................... 15
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APPLYING FOR CERTIFICATION

Welcome and Congratulations

ACRP would like to congratulate you on your decision to pursue certification in your chosen field of
work. As a professional in clinical research, you deserve to be recognized and appreciated for what you
do, and like most professionals, you want to become better at it. You look for opportunities for ongoing
professional development and practical ways to evaluate your own work that will help you develop as a
professional.

ACRP Certification Overview

In order to achieve certification, all applicants must meet the eligibility requirements and pass an exam.
Exams are administered twice annually, Spring and Fall, at over 600 testing centers in more than 80
countries.

The applicant should determine his/her own eligibility before submitting an application to the program.
Upon submission of a complete application, an eligibility review is conducted by ACRP. The candidate is
then notified of the eligibility review outcome via e-mail. All eligible candidates must then schedule an
appointment to take the exam.

Candidates who meet the eligibility requirements and pass the exam will be certified as having met ACRP’s
standards for becoming an ACRP-Certified Professional (ACRP-CP). Maintenance of one’s certification is
required every two (2) years.

Application Deadline
All application materials, including application, CV or resume, job description(s) and payment must be
received by February 8, 2019 for the February/March examination. Applications received by November
30, 2018 qualify for the Early-Bird rate.

Confidentiality
Application for, and achievement of, certification is between ACRP and an individual candidate.
Therefore, ALL application, eligibility, and exam details are confidential to the individual and cannot be
disclosed, regardless of payer. Only the candidate is permitted to withdraw an application or cancel an
exam appointment, regardless of payer.

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Application Process and Requirements

Professional Level Experience Requirements
To be eligible for the examination, an applicant must have the required minimum number of hours in the
professional practice of clinical research. Internship (paid or unpaid) or volunteer experiences will not
count toward the hours requirement.

NOTE: ACRP reserves the right to request backup documentation to substantiate the reported
information at any time during the application process and/or once the candidate has been certified.

ACRP-CP Eligibility Requirements

As defined by ACRP, and determined through its 2017 Job Analysis Survey, in order to be deemed
eligible to take the ACRP-CP exam, applicants must be able to provide evidence through a detailed job
description, detailed CV, or other documentation that they are involved in at least one of the following:

• Planning – protocol design, feasibility assessment, business operations (budgeting, contracting,

billing compliance), site selection activities, regulatory document preparation, collection, and/or
submission, site management activities, clinical operations role within site, academic medical
centers or CROs.

• Conducting – conduct of clinical trials with participants

• Overseeing (management, administration) – study site management (Site, CRO, Sponsor,

monitoring activities (including in-house, central and remote monitoring), project management,
quality control, quality assurance, data management, medical monitoring, safety monitoring
(medical safety liaison, pharmacovigilance, IRB professional).

Hours performing the requirements for the ACRP-CP certification can include hours documented up to
the date of the exam and/or through previous employment. The required number of hours is dependent
upon one’s educational background. See below:

ACRP-CP Eligibility Requirements

At least one of the options below should be met before applying for the ACRP-CP program.

Minimum Hours Required Documentation

Education Performing of Performed
Essential Duties Essential Duties
Detailed CV/résumé
 Bachelor’s Degree (or higher) and
Option 1 3,000 hours*
Job Description

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Detailed CV/Résumé
 Associate’s Degree OR
Option 2 4,500 hours* and
 LPN, LVN, RN
Job Description
Detailed CV/Résumé
 High School Diploma OR 6,000 hours*
Option 3 and
 Medical Assistant or Lab Technician
Job Description
*see section for options of substitutions for work experience

Substitution for Work Experience Requirements

Applicants may only choose one option below as a valid substitute. Under no circumstance will an
applicant be permitted to use more than one substitution for the same application.

Clinical Research Certifications (Option 1)

ACRP acknowledges that there is a shared knowledge base between CCRA, CCRC, and CPI designation
holders and those who seek the ACRP-CP designation. Any candidate for the ACRP-CP designation who
has a current CCRA, CCRC, or CPI designation will have achieved a valid substitute for 1,500 hours of the
required professional experience for the ACRP-CP exam.

Clinical Research Education Programs (Option 2)

ACRP considers applicants who have completed a clinical research degree that meets the following
standards to have achieved a valid substitute for 1,500 hours of professional experience for the ACRP-CP
program.

Acceptable programs must:

 Be a Completed Clinical Research Degree and;
 Be accredited by an accrediting agency recognized by the Council on Higher Education
Accreditation (CHEA) www.chea.org.

If an applicant opts to use an educational program as a substitute, he or she may send an email to
[email protected] for additional requirement details.

Application and Exam Fees

The cost to apply includes an exam and application fee, paid together at the submission of the
application. Credit card, check, or bank transfers are acceptable forms of payment. The fees are as
follows:

Member Non-Member
EARLY BIRD DATES $135 application fee $135 application fee
October 15 – November 30, 2018 $300 exam fee $350 exam fee
Total - $435 Total - $485
Member Non-Member
REGULAR DATES $135 application fee $200 application fee
December 1 – February 8, 2019 $325 exam fee $400 exam fee
Total - $460 Total - $600

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*The application fee is non-refundable regardless of eligibility status or cancellation.

Submission of the application confirms your understanding and agreement.

*If the applicant wishes to switch program type, they will be charged an additional application fee.

Application for Certification

Once an applicant has carefully self-determined he/she meets the eligibility requirements, the
application process can begin. Applications are submitted online.

If the applicant wishes to switch program type, they will be charged an additional application fee.

The following must be submitted together by the due date to be considered for review of eligibility:
1. Application Form AND
2. Supporting documents—curriculum vitae (CV)/ résumé AND
3. Detailed job description(s)* for positions listed on the CV/ résumé AND
4. Full payment

*If you cannot obtain a job description from your (former) employer, you may create and supply your
own. If necessary, you may contact ACRP at www.acrpnet.org/contact for a sample CV or job
description.

All documentation must be provided in English. If the original documentation was translated into
English, it must also be submitted in the original language, with the certified translated document.

Services for People with Disabilities

ACRP is committed to ensuring that no individual with a disability is deprived of the opportunity to take
an exam solely by reason of that disability. ACRP will provide reasonable accommodations for
candidates with disabilities pursuant to the Americans with Disabilities Act (ADA). The following
reasonable accommodations may be addressed:
 Wheelchair access is available at all established test centers.
 Candidates with visual, sensory, cognitive, or physical disabilities that would prevent them from
taking an exam under standard conditions may request reasonable accommodations and
arrangements.

To request a reasonable accommodation, one is required to check the designated box on the exam
application and also submit:
 Special Accommodations Form, signed by a licensed health professional approving the request
as accurate and reasonable. This MUST be submitted at the time of application.

Submitting the Application

The application process is now available online. The applicant will have the ability to start and save it
prior to submitting for formal review. Please note that all required documents must be included with

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application before payment can be processed online with a credit card.

If paying by check, complete and save application online. As the website cannot process check payments
online, please mail the check with your information clearly listed so that payment can be applied to your
application for submittal.

Submission of the application constitutes agreement that the candidate has read, understood, and
agrees to abide by the ACRP Code of Ethics and Professional Conduct. Applicants are required to sign a
Candidate Statement of Authorization and Agreement attesting to the accuracy of the information
provided as part of the application process. By submitting an application, the applicant consents to and
authorizes ACRP to verify the candidate’s academic and employment records.

Receipt of Application
An e-mail confirmation of payment is automatically sent once payment is processed. At that point,
applications will enter the Eligibility Review process.

THE ELIGIBILITY REVIEW PROCESS

Eligibility Review
The eligibility review process includes determining completeness of the application and whether or not
the applicant meets the eligibility criteria for the exam and performs all essential duties. Applicants
should expect to receive an update on application status (via email) within seven to ten days after the
application has been received.

Applicants will have seven (7) calendar days to respond to any request for additional information from
an eligibility reviewer. These requests will only come via e-mail.

Incomplete Applications
Applicants who do not respond to the requests for additional or clarifying information will automatically
have their applications determined ineligible and therefore will not be able to take the exam.

Eligibility Reviewers
An applicant may receive a request for additional and/or clarifying information from a reviewer in
support of his or her application. This is not unusual or uncommon. Reviewers only communicate via
email and are not available to speak with an applicant via phone concerning his or her application.
Therefore, it is imperative that an applicant contact ACRP in the event communication about the review
outcome has not been received through email.

Confirmation of Eligibility
Upon conclusion of review, an applicant will be found to be: eligible or ineligible.

Eligible applicants will be e-mailed an Eligibility Notice, with instructions as to how to schedule an exam

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appointment. Exam appointments can only be scheduled after eligibility is determined.

Ineligible applicants automatically receive up to two levels of review. Applicants are notified via e-mail
at each step of the review with an explanation of the deficiency identified. Each level of review can take
up to seven days. If after two reviews and the applicant is found Ineligible, a review will be conducted
by the Certification Manager and the applicant will be notified via email with the final result.

Ineligible applicants (who do not initiate the appeals process* within 15 days of notice) will be refunded
the exam fee and will need to re-apply and pay all fees if they decide to pursue certification in the
future.

*If the applicant is still determined to be ineligible after three levels of review, the applicant can choose
to appeal to the Academy Board of Trustees. However, after the third review, applicants can no longer
submit new documents to overturn an eligibility decision.

View ACRP’s Policy on Appeals.

ACRP-CP EXAMINATION INFORMATION

Exam Structure
The ACRP-CP Exam is designed as a practice-based exam to assess proficiency of the six (6) core
knowledge areas:
1. Ethical and Participant Safety Considerations
2. Investigational Product/Device Regulation
3. Clinical Trial Operations (GCPs)
4. Study and Site Management
5. Scientific Concepts and Research Design
6. Data Management and Informatics

Exam Delivery
The ACRP exam consists of 125 multiple-choice questions (25 of these questions are pre-test items, do
not affect a candidate’s score and are not identified to candidates). Each candidate is allowed a
maximum of three (3) hours to complete the 125 questions. Candidates are presented with a question
and are asked to choose the single best answer from the four options provided. Only one answer is
correct. There are no “trick” questions on the exam and there is no penalty for guessing.

Language
The exam is provided in English. Exam candidates may bring a hard-copy, translation only (word-to-
word) dictionary to the exam. Electronic dictionaries are not permitted. Dictionaries containing any
word definitions or other extraneous markings are strictly prohibited. The dictionary will be inspected by
the proctor before and after the exam is completed. No additional time is given to those using a
translation dictionary.

Exam Administration
ACRP partners with Prometric, a trusted provider of technology-enabled testing, to administer its exams.
Once a candidate has been found eligible, coordination of scheduling (including confirming, rescheduling

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or canceling) his or her exam will occur directly through or with Prometric via online or phone.

Examination Window
The candidate must test during the window for which he or she is approved. ACRP offers its exams each
year during two testing windows, spring and fall. The Spring 2019 testing window begins February 22,
2019 and concludes March 20, 2019. Candidates will not be permitted to schedule an appointment
outside of this testing window under any circumstances.

Exam Appointment Scheduling

The exams are administered via a secure network of computer-based testing sites. Over 600 locations in
more than 80 countries are available at which to take the exam. All candidates who have been found
eligible must schedule an appointment to take the exam. Candidates who do not schedule an exam risk
forfeiting all fees.

Appointments can be scheduled online (recommended) or by phone. To view testing locations, visit
www.prometric.com/acrp at any time.

Confirmation Number
When a candidate schedules his or her appointment, a confirmation number will be provided. Make
sure to keep a record of your confirmation number and appointment information. You will need your
confirmation number if you want to confirm, reschedule, or cancel your appointment with Prometric.

Confirming Your Appointment

It is the responsibility of a candidate to verify that they have been scheduled for the date, time, and place
he or she has requested. One may confirm his or her appointment in two ways:
 Confirm an appointment online at www.prometric.com/ACRP
 Call (800) 967-1139 or the applicable international number and select the option for confirming
your appointment
An appointment can be confirmed online even if scheduled via phone.

Rescheduling Your Appointment

Rescheduling an exam appointment is permitted by Prometric up to five (5) days BEFORE your scheduled
appointment. There may be fees associated with appointment changes. Rescheduling availability may
vary, depending on the test center location and number of days prior to the exam appointment date.

Candidates must contact Prometric directly to reschedule an exam appointment. ACRP cannot
reschedule your appointment. You may reschedule by phone or online and the appointment
confirmation number will be needed.

Cancellations, No Shows, Re-Examination, Refunds and Transfers

Cancellations
Candidates who wish to cancel their application may submit an Application Cancellation Request Form
to obtain a refund of the exam fee only. The application fee covers costs associated with reviewing the
application and is non-refundable.

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Emergency Cancellations
Candidates unable to keep their exam appointment due to an emergency situation within five (5) days
of the exam date, must submit an Emergency Cancellation Form and official documentation to ACRP at
www.acrpnet.org/contact. This information may be received up to seven (7) calendar days after the
candidate’s scheduled exam date.

The following situations will be considered with documentation: Emergency room visit or
hospitalization, severe medical condition requiring hospitalization, death of an immediate family
member (e.g., spouse, child/dependent, parent, grandparent, sibling), call to active military duty, or jury
duty.

No Shows and Missed Exams

If a candidate schedules an exam appointment and fails to take the exam, he or she forfeits all fees. If a
candidate arrives late for a scheduled exam appointment, he or she may not be allowed to test and,
subsequently, will not be eligible for a refund. Missed exams due to lateness are not eligible for a refund.

Re-Examination

ACRP offers its examinations each year during two testing windows, Spring and Fall.

Candidates who do not achieve a passing score on the certification examination will only be allowed to
re‐take the exam during the next available examination period by submitting a re‐examination fee.

If the candidate is not successful on this “re‐take” examination, he or she will need to complete a new
application and pay all fees in place at the time for any subsequent exams.

If a candidate chooses to transfer his or her first examination opportunity and, subsequently, does not
pass, he or she will need to complete a new application, meet all eligibility criteria in effect at that time,
and pay all fees in place at the time for any subsequent exams. Candidates who do not achieve a passing
score on their second attempt or who are unable to test again during the next examination period must
submit a new application, together with all current fees, to continue their pursuit of certification. Such
reapplications will be subject to all eligibility criteria in effect at that time. This policy protects the
security of the integrity of the examination by preventing item over-exposure. It is ACRP’s policy to
maintain two unique tests forms and update test items yearly to reduce any possible over exposure by
candidates by following the six-month waiting period. The time period between testing windows also
provides a sufficient amount of time for candidates to increase the amount of study or change their
method of test preparation. Candidates will not be permitted to schedule an appointment outside of
the testing windows under any circumstances.

Refunds
Refundable fee: examination fee only.
The application fee covers the cost associated with reviewing the application and therefore is non-
refundable.

No one other than the candidate may request a cancellation or refund.

Refunds are issued to candidates under two circumstances only: ineligibility or cancellation.

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Ineligibility
Ineligible applicants will receive a refund of the exam fee, within three weeks of the final ineligibility
notification.

Cancellation
To receive a refund, the cancellation request must be received at least five (5) calendar days BEFORE an
exam appointment. Requests within five days of an exam appointment will not be honored.

Refunds are not available to candidates who do not schedule or attend the exam.
Refunds will be sent to the party who initially paid for the exam. If payment was made by credit card,
that card will receive the credit. If that card is no longer valid, a check will be mailed. If the payment was
made by check, ACRP will mail a refund check to the original payer.

Transfers
ACRP offers a one-time transfer from the current exam offering to the next for a $50 fee. There are two
situations in which candidates may take advantage of this:
1. If a candidate is determined ineligible for the current exam window, but will have met the
eligibility requirements by the next exam window; or
2. If an eligible candidate withdraws from taking the original exam for any reason (up to five [5]
days before a scheduled exam appointment)

Transfers are applied toward the next exam only. Transfer of eligibility and associated fees will be
applied only to the original candidate and are not transferable to another person, even if paid for by a
third party. Exam fees are transferred toward the next exam only and not toward other products or
services.

If you choose to transfer to the next exam window for one of the two reasons above, you must submit
a request to transfer before the end of the exam window for which you had originally applied. To
submit a transfer request, you must access your online application and select Request Exam Window
Transfer.

If you have an exam appointment scheduled, you must first cancel it directly with Prometric before
submitting your online request to transfer to the next exam window. Fees, payable to Prometric directly,
apply for appointment cancellations made within thirty (30) to five (5) days prior to an appointment
date and do not include transfer fees paid to ACRP. Cancellations are not permitted less than five (5)
days prior to an appointment.

If a transfer candidate does not submit the request before the end of the current exam testing window,
then all funds originally submitted will be forfeited. Transferring is not an option for re-examination
candidates (from the previous exam cycle).

When a transfer request has been approved, all fees (application and exam fees) are applied
automatically at the start of the next application period. All eligible transfer candidates will receive an
email notice of Eligibility when the Eligibility ID has been reactivated and an exam appointment can be
scheduled. Contact www.acrpnet.org/contact if you did not receive your new Eligibility notice.
Candidates who are required to submit documentation for subsequent eligibility review must do so at

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the start of the next application period.

View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination

Preparing for the Exam

The best preparation is to understand the ACRP-CP knowledge requirements and their application to
clinical research. You might want to review the Detailed Content Outline for topics or subtopics with
which you are less familiar. If you find a particular area with which you are not familiar or comfortable,
that would be an area on which to focus your study or review. Or, you may want to do a surface review
of all the content areas, even those you believe you know well.

Because of the nature of the exam, there is not one comprehensive source to go to in order to study.
However, ACRP does recommend that you review the content areas covered on the exam by using the
Detailed Content Outline.

What’s Covered on the Exam?

Detailed Content Outline
The DCO is derived from the 2017 ACRP Job Analysis Survey, a careful description of the tasks performed
by an ACRP-CP candidate. Each question on the exam is based on this outline. Therefore, to prepare to
take the exam, one should study this outline and especially consider the underlying knowledge, skills,
and abilities needed to perform in his/ her role as a Certified Professional.

Study Texts
ACRP Certification exams are based on four ICH Guidelines and the Declaration of Helsinki:
• Guideline for Good Clinical Practice E6(R2);
• Definitions and Standards for Expedited Reporting E2A;
• General Considerations for Clinical Trials E8;
• Statistical Principles for Clinical Trials E9;
• Clinical Investigation of Medicinal Products in the Pediatric Population E11

ICH Guidelines
Declaration of Helsinki

Preparation Support
Certification Abbreviation List
The Abbreviations List contains abbreviations that may be used throughout the exam and exam Detailed
Content Outline. The abbreviations list is accessible on each screen during the exam and can be found
on our website.

IMPORTANT: ACRP DOES NOT sponsor or endorse any specific educational courses; even if the course is
advertised as a “prep” or “review” course for the exam. Those creating the course do not have ANY
inside information about the exam. Participation in these courses may help you learn or review topics
covered on the exam, but you should not expect them to directly cover exam content. The same
information that is included in this handbook to help you prepare is publicly available to those creating

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educational content.
Taking the Exam
It is important for candidates to understand their rights and responsibilities in the secure testing
environment of the Prometric test center. It is recommended that you review the full Policy on Testing
Experience Issues.

Exam Appointment Arrival

It is the candidate’s responsibility to arrive on time for the exam appointment. If the candidate is late by
15 minutes or more, the test center has the authority to turn the candidate away and not permit the
candidate to take the test. Plan to arrive 30 minutes before your appointment. If you miss your
scheduled exam appointment for any non-emergency reason (lack of child care, lateness due to work or
traffic, etc.) your opportunity to test will be lost.

Required Identification
To access a secure testing center you must present proper identification (ID) containing your legal name.
Examples of proper ID include a passport, driver’s license, state or government-issued ID.

Your legal name MUST match the first name and last name listed on your Eligibility Notice (emailed
from ACRP) and on the Appointment Confirmation (from Prometric). Middle names are excluded. Your
ID must meet each of the following criteria:
 government-issued AND
 current (non-expired) AND
 photo-bearing AND
 signature-bearing identification (ID)

The photo must look like the examinee. Signature on ID must match the signature provided during the
sign-in process. Major discrepancies will result in a candidate being denied from the testing center and
result in forfeiture of all fees paid.

If the name listed with ACRP and Prometric is not your legal name, you must submit a Name Change
Request online at www.acrpnet.org/contact immediately.

Exam Security and Test Center Guidelines

Prometric is serious about test center security. You will be presented with Prometric Test Center
Regulations upon arrival at the test site. Those who violate security will not have their exams scored or
processed, and will be required to leave immediately. Attempting to remove exam material or content
from the test center will result in severe consequences.

Once seated, you will follow a brief on-screen tutorial for navigating through the exam. Your exam will
begin after the tutorial. Each exam will be delivered via individual video-monitored testing carrels.
Immediately raise your hand at any time if your computer or any provided resources are not functioning
properly!

What Not to Bring: Any and all personal items will be locked in a locker. Examples include a purse, keys,
wallet, calculators, watch, cell phone, all electronic devices, tissues, outerwear (heavy coats), food, and

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all books and papers.

Attire: Prometric will not allow you to remove any article of clothing (headbands, jewelry, scarves,
shoes, light sweaters, etc.) that you wear into the room. Whatever you choose to wear, please plan to
wear the entire length of the exam.

Resources Available at the Test Center

The following resources will be available, issued only by the test center:
• An abbreviations list is also available on screen
• Hand-held calculator (an on-screen calculator is also available)
• Noise cancelling head set
• White board and dry-erase markers

Exam Scores
The passing scaled score for the exam is 600. A candidate scoring below 600 has not been successful on
the exam and cannot be certified.

One point is granted for each correct answer. There is no penalty assessed for an incorrect answer. The
number of questions answered correctly (or total points) is a candidate’s “raw score.” Prometric then
converts a candidate’s raw score to a scaled score. The "Total Scaled Score" will determine whether a
candidate has passed the exam. The exam is not scored on a curve and there is no predetermined
number of candidates permitted to pass. Your score does not depend on the other candidates testing
with you that day.

Note: The passing point set for the exam cannot be appealed.

Specific questions on the exam and/or answers to exam questions will not be discussed or released.
Due to the security of the item bank and because exam questions can be used on various exams, exam
questions will not be discussed with candidates and candidates may not have access to the exam or
their answers.

Note: For more information on scaled scoring, please contact www.acrpnet.org/contact.

Exam Results and Notification

The Score Report will be displayed at the end of the exam and emailed to the address that is provided to
Prometric during the scheduling of the exam. It is a required field when scheduling both online and by
phone. The email will also contain a link at the bottom that the candidate can click to Prometric’s
secured portal. The score report portal allows the candidate to log in with their appointment
confirmation number, and their last name, to print out duplicates of their score report if needed, at any
time. You will receive official confirmation of your certification status via email and postal mail,
approximately 30 days following the close of the testing window.

https://scorereports.prometric.com/

Candidates, are not yet considered certified until official notification of certification status is received

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from ACRP.

Candidates who pass the exam will be sent an official letter, a certificate, and Maintenance of
Certification information within 30 days after the close of the testing window. They will also be added to
ACRP’s Certification registry unless this option was de-selected at the time of application. The registry
will be updated within 30 days following the close of the testing window and can be accessed at
www.avectraacrp.com/Certlist.

Candidates who do not pass the exam are advised to review the content area proficiency ratings and use
this information to assist in preparing for future exams. Final exam results will not be given out over the
telephone or by fax, nor will results be sent to employers, schools, other individuals, or organizations
under any circumstances.

Appendix – CP Detailed Content Outline (DCO)

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Association of Clinical Research Professionals –

Certified Professional (ACRP-CP®) Examination
Detailed Content Outline
(Effective May 1, 2017)

This document contains the Detailed Content Outline (DCO) for the ACRP-CP. Each question on the exam
is based on this outline.

Introduction
In following best practices, the Academy conducted a Job Analysis Study to ensure content validity of
the ACRP-CP Examination. Program content validity is demonstrated with a comprehensive job analysis
conducted and analyzed by experts, with data gathered from practitioners within the profession. The
process utilizes knowledge and task focused guidelines to assess clinical research professionals’
competence, and determine the level of importance and frequency of specific knowledge and tasks
required to perform in the role of an ACRP-CP.

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Using the ACRP-CP Detailed Content Outline (DCO)

The ACRP-CP DCO was constructed from the results of a Job Analysis Study conducted Spring 2017. The
results of the study provided the framework for the knowledge and tasks important to the role of an
ACRP- CP and therefore the content of the exam. To be certified, an ACRP-CP is expected to have
proficiency in the six (6) main content areas of clinical research, displayed in the chart below. The
percent of questions dedicated to each content area are provided.

Percentage of Items
Content Areas on Exam
I. Ethical and Participant Safety Considerations 19%

II. Investigational Product/Device Regulation 16%

III. Clinical Trial Operations (GCPs) 25%

IV. Study and Site Management 23%

V. Scientific Concepts and Research Design 8%

VI. Data Management and Informatics 9%

Total 100%

The specific knowledge and tasks identified as important are provided in the ACRP-CP DCO listed below.
Therefore, to prepare to take the ACRP-CP Exam, one should study this outline and especially consider
the underlying knowledge, skills, and abilities needed to perform as an ACRP-CP. It is recommended that
an eligible candidate use this outline to identify knowledge gaps for constructing a relevant preparation
plan.

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Association of Clinical Research Professionals – Certified

Professional (ACRP-CP) Examination
Detailed Content Outline
(Effective May 1, 2107)

As defined by the most recent ACRP-CP Job Analysis Survey, an ACRP-CP® shall have proficient
knowledge in the following six (6) content areas of clinical research. An ACRP-CP typically uses this
knowledge to perform the tasks listed).

CPs must demonstrate

CPs typically perform the
Content Area proficient knowledge
following tasks:
within the following areas:
1. Ethical and Participant Safety 1.1 clinical care and clinical Compare and contrast clinical
Considerations (19%) management of research management of research participants
participants (e.g., standard of care vs protocol
requirements)
Develop and/or review informed
consent form
Verify continuity of medical care is
provided by study subjects
1.2 “clinical equipoise” and Compare and contrast clinical care and
“therapeutic misconception” as clinical management of research
related to the conduct of a clinical participants (e.g., standard of care vs.
trial protocol requirements)
Review the safety and expected
therapeutic effects of the
investigational product/device (e.g.,
using the investigator brochure)
Identify and/or address potential
and/or past ethical issues involved with
study conduct (e.g., cultural variations)
1.3 the requirements for human Develop and/or review informed
subject protections and privacy consent form
Differentiate the types of adverse
events (AEs) that can occur during
clinical trials, and their identification
and report process for AEs
Identify vulnerable populations and the
additional safeguards required
1.4 the principles and content of Develop and/or review informed
the key documents ensuring the consent form
protection of human participants Identify and/or mitigate safety risks
in clinical research Participate in and document the
informed consent process(es)

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1.5 the ethical issue involved Identify vulnerable populations and the
when dealing with vulnerable additional safeguards required
populations and the need for Develop, review, and/or implement
additional safeguards study plans and/or tools (e.g., subject
materials, recruitment plan, lab
manuals)
Evaluate potential conflicts of interest
1.6 the past and current ethical Identify and/or address potential
issues, and cultural variations as and/or past ethical issues involved with
they apply to the clinical study conduct (e.g., cultural variations)
development process Identify vulnerable populations and the
additional safeguards required
Identify and/or mitigate safety risks
1.7 why inclusion and exclusion Confirm the inclusion and exclusion
criteria are included in a clinical criteria assures human subject
protocol to assure human subject protection
protection Screen and/or confirm eligibility for
trial subjects
Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
1.8 the principles and methods of Identify and/or implement risk
risk versus benefit through management strategies (e.g., subject,
selection and management of investigational product/device, data
clinical trial subjects handling)
Evaluate and/or explain the benefits
versus risks for study subject
protections
Conduct initial risk assessment and
ongoing risk assessment review
1.9 adverse events classification, Differentiate the types of adverse
documentation, and reporting events (AEs) that can occur during
clinical trials, and their identification
and reporting process for AEs
Escalate significant issues as
appropriate
Comply with the safety reporting
requirements of regulatory agencies
both pre- and post- approval
1.10 blinding procedures Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
Develop and/or review unblinding
procedures as applicable

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Maintain unblinding procedures of

investigational product/device
1.11 components of subject Confirm the inclusion and exclusion
eligibility requirements criteria assures human subject
protection
Screen and/or confirm eligibility for
trial subjects
Assess, manage, and/or review subject
test results/safety data (e.g., timeliness,
accuracy, frequency, response)
1.12 confidentiality and privacy Comply with subject privacy regulations
requirements Identify and comply with the
requirements for human subject
protections and privacy under different
national and international regulations
and ensure their implementation
throughout all phases of a clinical study
Comply with electronic data
requirements (e.g., passwords and
access)
1.13 elements of the Investigator Review the safety and expected
Brochure therapeutic effects of the
investigational product/device (e.g.,
using the investigator brochure)
Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
Develop, update, and/or review the
Investigator’s Brochure
1.14 elements of the informed Compare and contrast clinical care and
consent form clinical management of research
participants (e.g., standard of care vs
protocol requirements)
Assess compliance and documentation
of consent process(es)
Participate in and document the
informed consent process(es)
1.15 informed consent/assent Participate in and document the
process requirements informed consent processes(es)
Assess compliance and documentation
of consent process
Compare and contrast clinical care and
clinical management of research
participants (e.g., standard of care vs
protocol requirements

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1.16 protocol deviation/violation Identify, manage, and report any

identification, documentation, and deviations from the protocol and
reporting process document as appropriate
Identify, investigate, and report
potential fraud and misconduct
Assess protocol compliance (visits,
procedures, reporting)
1.17 recruitment plan/strategies Evaluate the conduct and management
of clinical trials within the context of
applicable plan (e.g., protocol, study
plan, monitoring plan, data
management plan)
Continually evaluate subject
recruitment strategy and study
progress
Develop, review, and/or implement
study plans and/or tools (e.g., subject
materials, recruitment plan, lab
manuals)
1.18 safety monitoring Identify and/or mitigate safety risks
Differentiate the types of adverse
events (AEs) that can occur during
clinical trials, and their identification
and reporting process for AEs
Assess, manage, and/or review subject
test results/safety data (e.g., timeliness,
accuracy, frequency, response)
1.19 subject discontinuation Evaluate reasons for subject
criteria/procedures discontinuation (e.g., causes, contact
efforts)
Identify and/or manage adverse
event(s), (e.g., treat subject,
rechallenge, adjust treatment based on
subject need and protocol)
Verify continuity of medical care is
provided for study subjects
1.20 subject retention strategies Develop, review, and/or implement
study plans and/or tools (e.g., subject
materials, recruitment plan, lab
manuals)
Evaluate reasons for subject
discontinuation (i.e., causes, contact
efforts)
Continually evaluate subject
recruitment strategy and study
progress

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1.21 subject safety and privacy Identify and comply with the
issue management requirements for human subject
protections and privacy under different
national and international regulations
and ensure their implementation
throughout all phases of a clinical study
Comply with subject privacy regulations
Comply with electronic data
requirements (e.g., passwords and
access)
1.22 Conflicts of interest in clinical Evaluate potential conflicts of interest
research Identify and/or implement risk
management strategies (e.g., subject,
investigational, product/device, data
handling)
Evaluate study for feasibility (e.g., site
determining ability to successfully
conduct the study)
2. Investigational 2.1 the roles and responsibilities Evaluate and comply with the
Product/Device Regulation of the various stakeholders and regulatory requirements that are
(16%) regulatory institutions in the applicable for investigational
clinical trials product/device development and/or
research protocols
Identify roles and responsibilities as
defined by GCP guidelines
Oversee vendors (e.g., labs, IRB/IEC,
technology, subject recruitment, CRO)
2.2 the legislative and regulatory Evaluate and comply with the
framework that supports the regulatory requirements that are
development and registration of applicable for investigational
medicines, devices, and biologics product/device development and/or
and ensures their safety, efficacy, research protocols
and quality Identify and comply with the
requirements for human subject
protections and privacy under different
national and international regulations
and ensure their implementation
throughout all phases of a clinical study
Identify the ICH/GCP requirements for
data collection, corrections, and
queries
2.3 the specific processes and Identify and/or describe study design
phases that must be followed in Identify the ICH/GCP requirements for
order for the regulatory authority data collection, correction, and queries
to approve the marketing Comply with the safety reporting
authorization for a medical requirements of regulatory agencies for
product both pre-and post-approval

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2.4 regulatory reporting Comply with the safety reporting

requirements (e.g., pre- and post- requirements of regulatory agencies
approval, safety) both pre- and post- approval
Collect, maintain, verify, and/or store
regulatory essential documents
Differentiate the types of adverse
events that can occur during clinical
trials, and their identification and
reporting process for AEs
2.5 standards for handling Manage investigational product/device
hazardous goods, materials, and accountability, shipment, and use
biological samples (e.g., according to the research protocol
International Air Transport Conduct quality control activities in the
Association (IATA) conduct of clinical research
Develop and/or manage resources
necessary to conduct a study (the
financial, timeline, and cross-
disciplinary personnel)
2.6 audit and inspection processes Identify the process and purpose for
(preparation, participation, monitoring of the study
documentation, and follow-up) Conduct quality control activities in the
conduct of clinical research
Participate in audits and inspections
(e.g., prepare, support, respond)
2.7 clinical trial registries and Inform study subjects of trail results, in
requirements accordance with regulatory
requirements
Evaluate and comply with the
regulatory requirements that are
applicable for investigational
product/device development and/or
research protocols
Comply with the safety reporting
requirements of regulatory agencies
both pre- and post- approval
2.8 what constitutes fraud and Identify, investigate and report
misconduct potential fraud and misconduct
Participate in audits and inspections
(e.g., prepare, support, respond)
Assess investigator/site protocol
compliance
2.9 IRB/IEC reporting Comply with IRB/IEC requirements such
requirements as submission, review, and approval of
documents
Evaluate and comply with the
regulatory requirements that are
applicable for investigational

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product/device development and/or

research protocols
Oversee vendors (e.g., labs, IRB/IEC,
technology, subject recruitment, CRO)
2.10 IRB/IEC role, composition, Oversee vendors (e.g., labs, IRB/IEC,
and purpose technology, subject recruitment, CRO)
Assess qualifications of IRB/IEC
Identify and comply with the
requirements for human subject
protections and privacy under different
national and international regulations
and ensure their implementation
throughout all phases of a clinical study
2.11 protocol and protocol Comply with IRB/IEC requirements such
amendment submission and as submission, review, and approval of
approval processes documents
Identify issues potentially requiring
protocol amendments
Collect, maintain, verify, and/or store
regulatory essential documents
2.12 significant milestones in the Conduct initial risk assessment and
evaluation of efficacy and safety ongoing risk assessment review
(e.g., interim analysis result, Confirm and instruct subjects on
DSMB review) protocol requirements (e.g.,
investigational product/device, diaries,
visits
Confirm timely review of study data
3. Clinical Trial Operations 3.1 conduct and management of Identify the process and purpose for
(GCPs) 25% clinical trials within the context of monitoring of the study
applicable plans (e.g., protocol, Evaluate the conduct and management
study plan, monitoring plan, data of clinical trials within the context of
management plan) applicable plans (e.g., protocol, study
plan, monitoring plan, data
management plan)
Assess subject compliance (e.g.,
protocol, investigational
product/device, dairies/logs)
3.2 roles and responsibilities of the Identify roles and responsibilities as
clinical investigation team as defined by GCP guidelines
defined by GCP Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study
Oversee vendors (e.g., labs, IRB/IEC,
technology, subject recruitment, CRO)
3.3 design, conduct, and Identify and/or describe study design
documentation of clinical trials as Identify and/or implement risk
required for compliance with GCP management strategies (e.g. subject,

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investigational product/device, data

handling
Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
3.4 protocol required control, Review and/or document the process
storage, and dispensation of of appropriate control, storage, and
investigational products/devices dispensing of investigational products
Manage investigational product/device
accountability, shipment, and use
according to the research protocol
Manage and/or review investigational
product/device expiration and/or
manage resupply or relabeling
3.5 adverse events (AE’s) that Differentiate the types of adverse
occur during clinical trials, and the events (AEs) that can occur during
identification process for AEs clinical trials, and their identification
including SAEs and ADRs and reporting process for AEs
Identify and/or manage adverse
event(s) (e.g., treat subject,
rechallenge, adjust treatment based on
subject need and protocol)
Assess, manage, and/or review subject
test results/safety data (e.g., timeliness,
accuracy, frequency, response)
3.6 regulations and guidelines Develop and/or review informed
assuring human subject protection consent form
and privacy during the conduct of Identify and comply with the
clinical trials requirements for human subject
protections and privacy under different
national and international regulations
and ensure their implantation
throughout all phases of a clinical study
Comply with subject privacy regulations
3.7 reporting requirements Identify, manage, report any deviations
relating to clinical trial conduct from the protocol and document as
(e.g., SAEs, deviations, INDs, IRB) appropriate
Comply with IRB/IEC requirements such
as submission, review, and approval of
documents
Assess protocol compliance (visits,
procedures, reporting)
3.8 the processes and purposes for Identify the process and purpose for
monitoring of the study monitoring of the study

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Administer a data quality review

(source data/document review (SDR)
and/or verification (SDV))
Develop or participate in protocol
training
3.9 the purpose and process of Participate in audits and inspections
clinical trial audits and inspections (e.g., prepare, support, respond)
Create, document, and/or implement
corrective and preventative action
(CAPA)
Manage study records, retention, and
availability
3.10 identification, management, Assess protocol compliance (visits,
and reporting requirements for procedures, reporting)
protocol/GCP deviation/violation Provide or participate in study training
Identify, document, communicate, and
follow up on site issues
3.11 IRB/IEC requirements such as Coordinate protocol and/or protocol
submission, review, and approval amendments through appropriate
of documents approval processes (e.g., IRB/IEC,
sponsor, regulatory authority)
Comply with IRB/IEC requirements such
as submission, review, and approval of
documents
Identify, manage, and report any
deviations from the protocol and
document as appropriate
3.12 delegation of responsibilities Collect, maintain, verify, and/or store
regulatory essential documents
Assess qualifications of the
investigational site, site staff, and
principal investigator
Maintain and/or review study related
logs (e.g., site signature/delegation log,
screening log)
3.13 elements of an effective Create, document, and/or implement
corrective and preventive action corrective and preventive action (CAPA)
(CAPA) Identify and/or implement risk
management strategies (e.g., subject,
investigational product/device, data
handling)
Identify, document, communicate, and
follow up site issues
3.14 purpose and use of the Review the safety and expected
investigator’s brochure therapeutic effects of the
investigational product/device (e.g.,
using the investigator brochure)

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Develop, update, and/or review the

investigators brochure
Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
3.15 requirements of Obtain and/or confirm presence of a
indemnification/insurance signed indemnification/insurance,
contracts, and/or budgets
Develop and/or manage resources
necessary to conduct a study (the
financial, timeline, and cross-
disciplinary personnel)
Oversee vendors (e.g., labs, IRB/IEC,
technology, subject matter
recruitment, CRO)
3.16 source data review and Administer a data quality review
source data verification (source data/document review (SDR)
and/or verification (SDV))
Record, and/or review data for
accuracy and verifiability (e.g.,
completed eCRF/CRF)
Manage source data/documents
according to ALCOA-C standards
(Attributable Legible Contemporaneous
Original Accurate-Complete)
3.17 site selection activities Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study
Evaluate study for feasibility (e.g., site
determining ability to successfully
conduct the study)
Assess qualifications of the
investigational site, site staff, and
principal investigator
3.18 principal investigator Assess investigator/site protocol
responsibilities compliance
Evaluate the conduct and management
of clinical trials within the context of
applicable plans (e.g., protocol, study
plan, monitoring plan, data
management plan)
Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study

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3.19 project feasibility Evaluate study for feasibility (e.g., site

considerations determining ability to successfully
conduct the study)
Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study
Evaluate protocol for practicality of
execution
3.20 roles of various clinical trial Oversee vendors (e.g., labs, IRB/IEC,
entities (e.g., CROs sponsors, technology subject recruitment, CRO)
regulatory authorities) Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study
Identify roles and responsibilities as
defined by GCP guidelines
3.21 site initiation activities Provide or participate in study training
(e.g., site initiation visit, IM, webinar)
Prepare, conduct, and/or participate in
site monitoring (onsite, centralized, or
remote)
Develop or participate in protocol
training
3.22 site and study close-out Manage investigational product/device
activities recall
Perform data validations (issue, resolve,
close queries)
Prepare, support, and/or participate in
close out activities (site or study)
3.23 study personnel training and Provide or participate in study training
qualifications requirements (e.g., (e.g., site initiation visit, IM, webinar)
phlebotomy, IP administration, Verify appropriate staff, facility,
ECG, psychometric testing supplies, and equipment availability,
validation) throughout the study
Assess qualifications of the
investigational site, site staff, and
principal investigator
IV. Study and Site Management 4.1 quality management activities Conduct quality control activities in the
(23%) in the conduct of clinical research conduct of clinical research
Review Case Report Forms and
completion guidelines (e.g., CRF/eCRF)
Identify, document, communicate, and
follow up on site issues
4.2 resources necessary to Develop and/or manage resources
conduct a study (e.g., financial, necessary to conduct a study (the
timeline, and cross-disciplinary financial, timeline, and cross-
personnel) disciplinary personnel)

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Verify appropriate staff, facility,

supplies, and equipment availability
throughout the study
Evaluate study for feasibility (e.g., site
determining ability to successfully
conduct the study
4.3 methods used to track subject Develop, review, and/or implement
recruitment and study progress study plans and/or tools (e.g., subject
materials, recruitment plan, lab
manuals)
Continually evaluate subject
recruitment strategy and study
progress
Oversee vendors (e.g., labs, IRB/IEC
technology, subject recruitment, CRO)
4.4 responsibilities and Obtain and/or confirm presence of a
obligations involved in the signed indemnification/insurance,
conduct of a clinical trial (e.g. contracts, and/or budgets
legal, liabilities, accountabilities) Identify roles and responsibilities as
defined by GCP guidelines
Assess qualifications of the
investigational site, site staff, principal
investigator
4.5 procedures, documentation, Manage source data/documents
and oversight requirements of according to ALCOA-C standards
PIs, sponsors, contract research (Attributable Legible Contemporaneous
organizations (CROs), and Original Accurate-Complete)
regulatory authorities Identify the ICH/GCP requirements for
data collection, correction, and queries
Oversee vendors (e.g., labs, IRB/IEC,
technology, subject recruitment, CRO)
4.6 how to assess, manage, Review the safety and expected
and/or report adverse event (AE) therapeutic effects of the investigational
causality, severity, and product/device (e.g., using the
relationship to investigational investigator brochure)
product/device Differentiate the types of adverse
events (AEs) that can occur during
clinical trials, and their identification and
reporting process for AEs
Comply with the safety reporting
requirements of regulatory agencies
both pre-and post- approval
4.7 communication Manage study records retention and
documentation requirements availability
(e.g., telephone, email) Collect, maintain, verify, and/or store
regulatory essential documents

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Maintain and/or review study related

logs (e.g., site signature/delegation log,
screening log)
4.8 contractual agreements (e.g., Oversee vendors (e.g., labs, IRB/IEC,
budgets, clinical trial agreement) technology, subject recruitment, CRO)
Obtain and/or confirm presence of a
signed indemnification/insurance,
contracts, and/or budgets
Evaluate potential conflicts of interest
4.9 corrective and preventive Create, document, and/or implement
action (CAPA) processes corrective and preventive action (CAPA)
Identify, document, communicate, and
follow up on site issues
Escalate significant issues as appropriate
4.10 maintenance and use of Oversee vendors (e.g., labs, IRB/IEC,
equipment and supplies technology, subject recruitment, CRO)
Perform and/or verify equipment
calibration and maintenance
Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study
4.11 investigational Maintain and/or review study related
product/device accountability and logs (e.g., site signature/delegation
documentation requirements screening log)
Assess protocol compliance (visits,
procedures, reporting)
Manage and/or review investigational
product/device expiration and/or
manage resupply or relabeling
4.12 investigational Review the protocol and supporting
product/device use (e.g., dosing documentation (e.g., investigators
schedule, frequency, expected brochure, instructions for use, package
side effects) insert)
Manage investigational product/device
accountability, shipment, and use
according to the research protocol
Identify and/or implement risk
management strategies (e.g., subject
investigational product/device, data
handling)
4.13 investigational Develop, update, and/or review the
product/device reference Investigators Brochure
materials (e.g., investigator Review the protocol and supporting
brochure, instructions for use, documentation (e.g., investigators
user manual) brochure, instructions for use, package
insert)

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Maintain unblinding procedures of

investigational product/device
4.14 investigational Evaluate and comply with the regulatory
product/device storage and requirements that are applicable for
disposition investigational product/device
development and/or research protocols
Manage investigational product/device
recall
Escalate significant issues as appropriate
4.15 non-compliance Escalate significant issues as appropriate
management Assess protocol compliance (visits,
procedures, reporting)
Identify, document, communicate, and
follow up on site issues
4.16 sample collection, storage, Manage and/or review investigational
disposal, and shipment product/device expiration, and/or
requirements manage resupply, or relabeling
Manage study records retention and
availability
Development, review, and/or
implement study plans and/or tools
(e.g., subject materials, recruitment
plan, lab manuals)
4.17 how to assess subject Confirm and instruct subjects on
compliance protocol requirements (e.g.,
investigational product/device, diaries,
visits)
Assess subject compliance (e.g.,
protocol, investigational product/device,
diaries/logs)
Evaluate reasons for subject
discontinuation (i.e., causes, contact
efforts)
4.18 subject responsibilities for Confirm and instruct subjects on
study participation protocol requirements (e.g.,
investigational product/device, diaries,
visits)
Assess protocol compliance (visits,
procedures, reporting)
Participate in and document the
informed consent processes
4.19 subject visit activities Assess subject compliance (e.g.,
protocol, investigational product/device,
diaries/logs)
Assess protocol compliance (visits,
procedures, reporting)

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Assess, manage, and/or review subject

test results/safety data (e.g., timeliness,
accuracy, frequency, response)
4.20 vendor management (e.g., Oversee vendors (e.g., labs, IRB/IEC,
labs, IRB/IEC, technology, subject technology, subject recruitment, CRO)
recruitment, CRO) Evaluate study for feasibility (e.g., site
determining ability to successfully
conduct the study)
Identify, investigate, and report
potential fraud and misconduct
4.21 principal investigator Identify, investigate, and report
oversight requirements potential fraud and misconduct
Assess investigator/site protocol
compliance
Verify appropriate staff, facility,
supplies, and equipment availability
throughout the study
4.22 identification and reporting Assess protocol compliance (visits,
requirements for protocol procedures, reporting)
deviations/violations Assess subject compliance (e.g. protocol,
investigational product/device,
diaries/logs)
Identify, document, communicate, and
follow up on site issues
4.23 study evaluation for Evaluate study for feasibility (e.g., site
feasibility (site determining ability determining ability to successfully
to successfully conduct the study) conduct the study)
Assess investigator/site protocol
compliance
Assess qualifications of the
investigational site, site staff, and
principal investigator
4.24 reviewing and interpreting Assess, manage, and/or review subject
values for lab and test results test results/safety data (e.g., timeliness,
accuracy, frequency, response)
Confirm timely review of study data
Identify and/or manage adverse event(s)
(e.g., treat subject, rechallenge, adjust
treatment based on subject need and
protocol
4.25 subject discontinuation Evaluate reasons for subject
process discontinuation (i.e., causes, contact
efforts)
Assess subject compliance (e.g. protocol
investigational product/device,
diaries/logs)

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Verify continuity of medical care is

provided for study subjects
4.26 protocol and protocol Identify issues potentially requiring
amendment implementation protocol amendments
process (e.g., approvals, Implement the administrative and/or
resubmission, re-consent) clinical tasks for protocol amendments
Evaluate protocol for practicality of
execution
V. Scientific Concepts and 5.1 clinical trial design (e.g., Identify and/or describe study design
Research Design (8%) double-blind, cross-over) Identify and/or describe study
hypothesis, objective(s), and endpoints
Evaluate the conduct and management
of clinical trials within the context of
applicable plans (e.g., protocol study
plan, monitoring plan, data
management plan)
5.2 elements of a protocol Review the protocol and supporting
documentation (e.g. investigators
brochure, instructions for use, package
insert)
Compare and contrast clinical care and
clinical management of research
participants (e.g., standard of care vs
protocol requirements)
Develop or participate in protocol
training
5.3 elements of an Investigational Develop, update, and/or review the
Brochure (IB) and/or Investigators brochure
investigational device use Review the safety and expected
(instructions for Use) therapeutic effects of the investigational
product/device (e.g., using the
investigator brochure)
Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
5.4 rationale for subject eligibility Identify vulnerable populations and the
requirements (e.g., vulnerable additional safeguards required
populations, safety) Identify and/or mitigate safety risks
Screen and/or confirm eligibility for trial
subjects
5.5 rationale for complying and Assess protocol compliance (visits,
consequences for noncompliance procedures, reporting)
with a protocol (e.g., scientific Integrate risk-based approach to quality
validity) management and monitoring
Create, document, and/or implement
corrective and preventive action (CAPA)

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5.6 risk management strategies Integrate risk-based approach to quality

and principles (e.g., quality management and monitoring
management systems) Conduct initial risk assessment and
ongoing risk assessment review
Identify and/or implement risk
management strategies (e.g., subject,
investigational product/device, data
handling)
5.7 study objective(s), Identify and/or describe study
hypotheses, and end hypothesis, objective(s) and endpoints
points/outcomes Review the protocol and supporting
documentation (e.g., investigators
brochure, instructions for use, package
insert)
Identify and/or describe study design
5.8 treatment assignments (e.g., Identify and/or describe study design
randomization, open label, Review the protocol and supporting
registries) documentation (e.g., investigators
brochure, instructions for use, package
insert)
Comply with randomization procedures
of investigational product/device
VI. Data Management and 6.1 basic concepts of biostatistics Perform data validations (issue, resolve,
Informatics (9%) and informatics in research close queries)
Identify and/or describe study
hypotheses, objective(s) and endpoints
Evaluate protocol for practicality of
execution
6.2 flow of data throughout a Confirm timely review of study data
clinical trial Identify the ICH/GCP requirements for
data collection, correction, and queries
Review Case Report Forms and
completion guidelines (e.g. CRF/eCRF)
6.3 process of electronic data Develop and/or utilize study
capture (e.g., edit specifications, management tools
security, audit trails) Comply with electronic data
requirements (e.g., passwords and
access)
Confirm timely review of study data
6.4 requirements for data Confirm timely review of study data
collection, correction, and queries Administer a data quality review (source
(e.g., completion guidelines) data/document review (SDR) and/or
verification (SDV))
Prepare, conduct, and/or participate in
site monitoring (onsite, centralized, or
remote)

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6.5 data quality systems Administer a data quality review (source

data/document review (SDR) and/or
verification (SDV))
Comply with electronic data
requirements (e.g. passwords and
access)
Confirm timely review of study data
6.6 data privacy principles Comply with electronic data
requirements (e.g. passwords and
access)
Identify the ICH/GCP requirements for
data collection, correction, and queries
Conduct quality control activities in the
conduct of clinical research
6.7 purpose of pharmacovigilance Assess, manage, and/or review subject
(e.g., CIOMS, IDMC/DSMB, safety test results/safety data (e.g., timeliness,
databases) accuracy, frequency, response)
Identify and comply with the
requirements for human subject
protection and privacy under different
national and international regulations
and ensure their implementation
throughout all phases of a clinical study
Differentiate the types of adverse
events (AEs) that can occur during
clinical trials, and their identification and
reporting process for AEs
6.8 essential documents for the Manage study records retention and
conduct of a clinical trial (e.g., availability
trial master file) Maintain and/or review study related
logs (e.g., site signature/designation log,
screen log)
Collect, maintain, verify, and/or store
regulatory essential documents
6.9 record retention and Collect, maintain, verify, and/or store
destruction practices and regulatory essential documents
requirements Manage study records retention and
availability
Maintain and/or review study related
logs (e.g., site signature/delegation log,
screening log)
6.10 source data/document Administer a data quality review (source
review (SDR) and/or verification data/document review (SDR) and/or
(SDV) verification (SDV))
Manage source data/documents
according to ALCOA-C standards

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(Attributable Legible Contemporaneous

Original Accurate Complete)
Prepare, conduct and/or participate in
site monitoring (onsite, centralized, or
remote)
6.11 study documentation Manage source data/documents
practices (ALCOA-C) according to ALCOA-C standards
(Attributable Legible Contemporaneous
Original Accurate-Complete
Administer a data quality review (source
data/document review (SDR) and/or
verification (SDV))
Prepare, conduct, and/or participate in
site monitoring (onsite, centralized, or
remote)
6.12 PI responsibility to make all Manage study records, retention, and
source records available for availability
monitoring, auditing, and Identify, document, communicate, and
inspection follow up on site issues
Participate in audits and inspections
(e.g. prepare, support, respond)

ACPR-CP Certification Handbook – September 2018