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)

Planning Research

 

Study Design Facilities Scientific Peer Review Secure Funding Prepare study documentation Sponsorship Protocol Contracts Registration on public database Finalise study documents Statutory Approvals Ethics Review