The study sponsor is ultimately responsible for the study design. NHS/HSC organisations are however responsible for reviewing protocols to ensure that risks to the study are addressed through the local study management arrangements. Study-wide review provides assurance that the study documents describe the study clearly, consistently, and accurately.
3.1 Protocol assessment
Introduction
The protocol should describe the objectives, design, methodology, statistical considerations (or other methods of data analysis) and the management arrangements for of the study including the definition of the end of the study. In most cases this will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol. For studies involving human tissue, the analysis of the samples should be undertaken as part of the data collection before the end of study is declared. Samples may be retained for up to 12 months after the end of the study for the purpose of data verification. Where this is intended, it should be included in the protocol. It is recommended that a protocol describes the monitoring of the study and dissemination of the study findings. The content of a protocol may vary depending on study type, but all protocols should provide a clear description of the study activities, to ensure that the study may be conducted as intended in a consistent and repeatable fashion. A study must follow the protocol agreed by the study sponsor and approved by the relevant regulatory bodies. It is the Sponsor’s responsibility to ensure that the study has scientific review that is proportionate to the study type.
Protocol templates for CTIMPs and qualitative research are available on the IRAS Help pages, whilst their use is not mandatory, they set out the organisation and detail expected from a protocol.
Study wide reviewers should note that, where information is not provided in the study protocol it may be acceptable for this to be provided in separate, supplementary information.
Study-wide considerations
Confirm that the protocol clearly describes the activities to be undertaken at the NHS research site(s) and, as applicable, PICs and other participating NHS organisations. In particular, unless this information is (or the sponsor asserts will be), provided in other documents this should include:
- the arrangements for how study participants should be identified, approached and consented and what processes and activities participating NHS/HSC organisations will need to undertake to deliver this according to the sponsors requirements (including where this differs between different types of participating NHS/HSC organisations)
- the arrangements for the collection, use, storage, analysis and destruction of human tissue samples at participating NHS organisations
- the arrangements for the collection, use, sharing, security and integrity of participant data, including what will happen to it following the end of the study and what processes and activities participating NHS/HSC organisations will need to undertake to deliver this according to the sponsors requirements (including where this differs between different types of participating NHS/HSC organisations)
Check that the protocol maintains consistency with other study documents to accurately and consistently describe the study.
Check that the protocol includes a clear definition of the end of the study and that this is consistent with other study documents and national expectations.