Biomedical & Scientific Research Ethics Committee (BSREC)
Study Amendments Guidance
A substantial amendment is defined as an amendment to the terms of the application, or to the protocol
or any other supporting documentation, that is likely to affect to a significant degree:
1.
2.
3.
4.
The safety or physical or mental integrity of the subjects of the study;
The scientific value of the study;
The conduct or management of the study; or
The quality or safety of any investigational medicinal product used in a trial.
Some changes, however, will have no significant implications for participants or for the conduct,
management or scientific value of the study and can be regarded as ‘non-substantial’ or ‘minor’
amendments.
Substantial Amendments require approval from BSREC before they can be implemented. See below for
the application process.
Non-Substantial Amendments do not require approval from BSREC before they can be implemented.
It is the responsibility of the Chief Investigator to determine whether an amendment is substantial, and
to seek approval as appropriate.
The deliberate misclassification of an amendment to a study could be deemed to be research
misconduct, and investigated as such by the University.
Substantial Amendments – Examples
1. Changes to the design or methodology of the study, or to background information affecting its
scientific value;
2. Changes to the procedures undertaken by participants; any change relating to the safety or
physical or mental integrity of participants, or to the risk/benefit assessment for the study;
3. Significant changes to study documentation such as participant information sheets, consent
forms, questionnaires, letters of invitation, letters to GPs or other clinicians, information sheets
for relatives or carers;
4. A change of sponsor(s) or sponsor’s legal representative;
5. Appointment of a new chief investigator or key collaborator;
6. A change to the insurance or indemnity arrangements for the study;
7. Inclusion of a new trial site (not listed in the original application) in a CTIMP;
8. Appointment of a new principal investigator at a trial site in a CTIMP;
9. Temporary halt of a study to protect participants from harm, and the planned restart of a study
following a temporary halt;
10. A change to the definition of the end of the study;
11. Any other significant change to the protocol or the terms of the BSREC application.
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Non-Substantial Amendments – Examples
1. Minor changes to the protocol or other study documentation, e.g. Correcting errors, updating
contact points, minor clarifications;
2. Updates of the investigator's brochure (unless there is a change to the risk/benefit assessment
for the trial);
3. Changes to the chief investigator’s research team (other than appointment of key collaborators);
4. Changes to the research team at particular trial sites (other than appointment of a new principal
investigator in a CTIMP);
5. Changes in funding arrangements;
6. Changes in the documentation used by the research team for recording study data;
7. Changes in the logistical arrangements for storing or transporting samples;
8. Inclusion of new sites and investigators in studies other than CTIMPs;
9. Extension of the study beyond the period specified in the application form.
Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator, or other
study staff are minor amendments, but should be notified to BSREC for information.
Substantial Amendments: Application Process
Applicants should complete the Substantial Amendment Application Form, and submit it to BSREC, along
with copies of any study documentation that is being altered as part of the amendment.
Please amend the protocol and other relevant documentation, highlighting the changes you have made
so that they are easy to locate. Any amended documents need to have different version numbers to
those originally submitted and approved e.g. Version 2, with the new date of implementation.
Before submission, the form must be signed by the Chief Investigator, and, for student applications, by
the Academic Supervisor, to indicate support for the amendment.
When completed please email the revised document(s), together with the completed application form
(with signatures), to: BSREC, via bsrec@warwick.ac.uk
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