Prepare Study Documentation

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)