Standard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office
(SOP)
Research and Development Office
Signed:
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Table of Contents
1. Purpose
2. Introduction
3. Scope
4. Procedure
4.1 Data Management Process
4.2 Coding CRF Responses
4.3 Data Entry
4.4 Data Cleaning and Validation
4.5 Data Protection
4.6 Data Backup System
4.7 Independent Data Monitoring Committees
5. Regulations, Guidelines, References SOP Links etc
6. Appendices
1. INTRODUCTION
ICH GCP Guidelines specify that appropriately qualified individuals should supervise
the trial data handling, verify the data and conduct the statistical analyses (ICH 5.5).
This SOP will not describe procedures for developing the Case Report Form data
collection tool.
2. OBJECTIVE
This SOP describes the data management processes for South Eastern Health and
Social Care Trust (SEHSCT) sponsored clinical trials and other research projects,
specifically the processes involved with collecting, validating and analysing such
data.
3. SCOPE
This SOP applies to all clinical trials and other research projects sponsored by the
SEHSCT. Where the data management has been outsourced to a third party, such
as a Clinical Trials Unit, it may be appropriate to follow their SOP for data
management.
This SOP does not apply to commercially funded research or research sponsored by
an external non-commercial organisations.
4. PROCEDURE
The process of data management involves converting the data collected using data
collection tools, most commonly Case Report Forms (CRFs), into electronic data that
can then be statistically analysed.
Although the above list is not exhaustive it provides a basis for the Data Management
Plan that can be adapted and expanded as necessary.
Once the CRF has been designed in accordance with the protocol; the database to
store the information collected should be designed. Depending on the size and type
of study a MS Excel spreadsheet may be sufficient or an alternative Data
Management System may be used. When developing a database points to consider
include:
Clinical data also needs to be coded for recording of all adverse events. The World
Health Organisation Adverse Reaction Terminology (WHO-ART) and Medical
Dictionary for Regulations Activities (MedDRA) both have a system of coding to
assist with this categorised by System Organ Class. A code is assigned for each
disease and adverse reaction. You can access WHO-ART and MedDRA through
http://www.umc-products.com/graphics/3149.pdf and
http://meddramsso.com/MSSOWeb/index.htm respectively.
The coding can be done at various stages of the trial such as: during the initial data
collection from the participant by the investigator or research nurse; after the data
collection, but prior to entering the data on the database; or when the data are
entered onto the database.
On initial receipt of CRF, the form should be date stamped and checked for initial
missing or incomplete responses. If any inconsistencies are found these should be
queried with the investigator and a record should be kept of all queries sent out.
Instructions for sites to respond to data queries should include no use of Tippex, not
to obscure the original data entry and to initial and date any amendments made.
Once the paper CRFs are completed, the data must then be entered onto the
database. Trained data entry staff should do data entry. For multicentre studies
where the CRFs are being sent to a coordinating centre for data entry, a copy of the
CRF should be retained by the Investigator, with the original (usually 2 copies from
No Carbon Required Paper CRFs) going to the coordinating centre. The
coordinating centre should keep a log of all CRFs received.
All stored CRFs should be kept in a secure environment such as a locked filing
cabinet in a locked room. Secure also means protection against environmental
damage such as damp or fire, without water sprinklers.
ii. When data are entered in the database by data entry staff
During data entry the two methods for validation described above (4.3.1) can
be used i.e. data entry checks or double data entry. Where data entry checks
are used, if the study database has software enabled for automatic data entry
checks, an Edit Check Specification (ECS) document should be put together
by the clinicians/statisticians/data staff involved with the study. The ECS
should provide full details of the data entry checks that have been set up, and
all checks should be tested before the trial begins.
Depending on the database software, it is also advisable to set up warnings to
alert data entry staff when values are entered outside of the expected range,
or if the type of entered data is incorrect e.g. a numeric value entered rather
than text. It is also useful to set up alerts for missing values where possible.
iii. When data have been entered and are available for the data manager
At this stage it is advisable to carry out systematic post-entry computer tests.
Lists should then be created (either through automatic database software
systems, or manually) of the following data queries:
All missing values will be listed
All values outside of pre-defined range
All checks should be defined before the study starts, and should be described in the
Edit Check Specification document described previously. Data validation should
continue until all missing values and inconsistencies are corrected or clarified.
During the entire data management and validation process it is essential that all
study data are kept in a secure location and in accordance with the terms of the Data
Protection Act 1998. Participant confidentiality must be maintained at all times and
all study records should be kept in pseudonymised form identifying participants by
their study code rather than name, initials or hospital number.
Any paper CRFs should be kept in locked filing cabinets in locked rooms only
accessible by authorised personnel. The key to the participant code list should be
kept separately to these documents, again in a locked, secure location. If paper
CRFs must be transferred to a coordinating centre for data entry, they should be sent
either by courier or registered post to minimise the risk of losing data. A log should
always be maintained of documents sent and received at each centre involved. If
electronic data transfer is used, this should be via a secure system, password
protected and encrypted where possible.
Whatever the format of the database software used to manage the study data, there
should always be a back-up system in place to guard against loss of data due to
software or environmental disaster. The SEHSCT IT service has a data backup
service that provides a reliable means of protecting data held on departmental and
research groups file servers. IT does not backup files on local desktop machines.
Owners of such machines are responsible for protecting local files.
The data reviewed by the IDMC should be as up to date as possible and should be
validated up to the point of interim analysis to ensure it is of sufficient quality. The
membership of the committee should be independent to the research team. The
results should be reviewed at regular intervals as sufficient data accumulate. If there
is a Trial Steering Committee (TSC) for the study, the IDMC would normally make
their recommendations for action through them or alternatively to the Chief
Investigator (CI).
6. APPENDICES
None