Study file content

Essential documents

Essential documents allow the conduct of the trial and quality of data produced to be evaluated. The documents provide evidence that those involved in the trial (sponsors, investigators and monitors) adhered to good clinical practice standards and applicable regulatory requirements.

File management

The Research and Development (R&D) team have produced checklists to simplify the set up of trial master and investigator site files.

The site files should be indexed (dividers are also recommended) to ease locating documents and finding files.

Documents should be filed in a timely manner to aid the management of the study. The file notes template can be downloaded and used but cannot be retracted once written as it provides a study record.

Single site studies can combine trial master and investigator site files.

Storage

Trial master and investigator site files must be stored securely and only accessed by those involved in the study.

Study sponsors and investigators should keep a record of their respective essential and source document locations.

The storage system used during the study and to archive it, irrespective of the type of media used, should allow documents to be:

• identified
• version controlled
• searched
• retrieved

Replacement documents should fulfil the certified requirements of the original version (e.g. source documents or case report forms).

Inspectors have the right to directly access trial master and investigator site files.

Version control

It is important to keep clear accurate version control of all trial related documents. This includes:

• protocols
• patient information sheets
• consent forms
• GP letters
• trial specific procedures
• standard operating procedures

The current version of all approved study documents must be in the investigator site file. All previous versions of documents must be:

• retained in the investigator site file
• clearly marked as superseded
• initialled
• dated

Before the study starts

The chief/principle investigator must ensure a member of the study team is delegated the role of setting up and maintaining study files.

The documents outlined below should be on file before the study starts but may vary depending on the nature of the study.

• Study file content list
• Ethics applications
• UHB approval letters
• R&D approval letters
• Ethics approval letters
• Contracts and agreements (e.g. clinical trial, confidentiality, chief/principle investigator and clinical director agreements)
• Ionising radiation medical exposure regulations
• Administration of radioactive substances advisory committee approval 
• Study protocol
• Blank forms (e.g. patient information sheets, informed consent forms, case report forms and serious adverse event forms)

Study start up

The following essential documents should be ready for the start of the study:

• Updated study file content list
• Meeting minutes from the study start up or kick off meeting
• Delegation of duties log that includes signatures
• Up-to-date CVs of staff listed in the delegation of duties log
• Applicable training certificates (e.g. good clinical practice)
• Study initiation report. This may be produced following a study sponsor start up visit
• Subject screening and recruitment logs*
• Completed informed consent forms

*Subject identifiable information should be restricted to completed informed consent forms and screening logs.

Study duration

The following essential documents should be updated throughout the study:

• Study file content list
• Study team meeting minutes. This depends if the chief/principle investigator sets up study team meetings
• Action logs arising from meetings
• Study protocol and any amendments
• Study data. Paper forms should be filed and electronic form data location stated in a file note
• Completed case record forms
• General study related correspondence

Study completion or termination

On completion or termination of the study, the team should check that:

• all study files are complete and up-to-date
• terminated study files are up-to-date
• an archivist has been named and identified if the sponsor has delegated archiving to the chief/principle investigator
• an archive location has been identified
• any outstanding actions have been resolved
• all required reports (i.e. research ethics committee, medicines and healthcare products regulatory agency, R&D or sponsor) have been completed or actioned
• all services or departments have been informed (e.g. Pharmacy, Imaging, R&D or NIHR Wellcome Trust Clinical Research Facility)

Document retention

Research teams may wish to retain some documentation at the study site. This may include clinical trial agreements, proof of business and traceability matrices (where appropriate).

Copies of retained documents should remain with the study file to ensure it is complete when archived. The study file should also contain a list of retained documents with the location of any original retained documents.

The document retention period may be as long as the documents are archived or proof of business is required.

Archiving documents

Archive arrangements should be agreed with the study sponsor at the start of the study.

If an archive agreement was not in place at the start of the study, the investigator should contact the sponsor to confirm archive arrangements.

Quality records

Quality records include the R&D study file content list and chief investigator agreement.