Prepare Study Documentation
Study Documentation will need to be in place before the study can begin.
The following list is a guide relating to documentation that should be in place before a study begins. This list is not exhaustive.
- Confirmation of Sponsorship letter
- Final approved study protocol signed by CI and Statistician
- Final approved participant information sheet(s) and consent form(s) and GP letter
- Final approved other written participant information e.g. diary card(s)
- Final approved participant recruitment advertisement (if relevant)
- Research ethics committee (REC) approval
- NHS R & D Approvals
- Clinical Trial Authorisation (CTA}
- Final approved risk assessment document and any monitoring plan
- Example of Case Report Form
- Signed off/finalised clinical database
- Details of any data monitoring committee or trial steering or management group / Charters
- Access to all relevant standard operating procedures (SOPs) and evidence of Training in these
- Investigator’s Brochure or Summary of Product Characteristics
- Signed agreements including operational and financial arrangements
- Statement of insurance to document compensation to participants for trial-related injury (non NHS)
- CVs and other evidence of relevant training (e.g. GCP/Regulation/protocol) and qualifications for the investigator(s) and local study team members
- Normal values/ranges for laboratory/medical/technical tests/procedures
- Laboratory accreditation(s)
- Pharmacy documentation/file
- Decoding procedures for blinded trials
- Template logs including delegation logs, screening/enrolment logs, participant identification log, randomisation logs (where applicable)
- Trial start-up/initiation report (or confirmation that site initiation activities have been completed)