How to guide: Site file maintenance

Most studies will require that a site file be held and maintained by each recruiting site. Site files are often provided by the study team and may be in paper or electronic format.

Key information you should be aware of:

A site file must contain current versions of all documents being used in the study. Previous versions must be kept in the file but crossed through and marked ‘superseded’.

  • The site file must also contain delegation logs and research CVs for all persons listed in the delegation log.
  • Site files may be checked by sponsors or study monitors at any time.
  • Site files may be held electronically if agreed by the study sponsor.
  • Site files must be kept securely, but accessible by persons delivering the study for reference.

View additional site selection/initiation visit (SIV) guides

Highlight

The National Institute for Health Research (NIHR) provides a comprehensive list of suggested site file contents: https://www.nihr.ac.uk/documents/suggested-investigator-site-file-contents/11537

Full guide

Contents:

Site files are often provided by the study team and may be in paper or electronic format.

The NIHR has provided a comprehensive list of suggested investigator site file contents, recommending the inclusion of a contents page, and advising that each section should be signed and dated upon completion: https://www.nihr.ac.uk/documents/suggested-investigator-site-file-contents/11537:

Please note, this is a suggested contents list. Please discuss a study’s site file with the study team; they will often provide the site file and request that the site keep this maintained. The NIHR website gives the following suggested list of what you might want to keep in a site file (if not provided by the study team):

  • Section 1 – Protocol / amendments – to include: current protocol, protocol amendments, historical protocols
  • Section 2 – Sample CRF/ QLQ Diary Cards. Note: If too bulky to put in file place file note in this section stating where it can be found.
  • Section 3 – Regulatory approval documentation
  • Section 4 – Site signature /responsibility log
  • Section 5 – Curriculum Vitae. Note: CVs for all research personnel listed in the signature/responsibility log should be included.
  • Section 6 – Patient Identification form and Patient recruitment /screening form
  • Section 7 – Sample of current and all historical Patient Information / Informed Consent form and GP Letter. Completed patient Information and Informed Consent Forms.
  • Section 8 – Correspondence. Note: File in chronological order all correspondence to/from the coordinating research body. File email communication. Include a separate section here for newsletters.
  • Section 9 – Minutes from the initiation meeting, monitoring logs and notes of telephone calls. Note: If the study is not monitored then state this in a file note in this section. Document telephone call in relation to agreements or significant discussions regarding trial administration, trial conduct, adverse events or protocol violations.
  • Section 10 – Blank serious adverse event forms and guidelines for their completion.
  • Section 11 – Notification of serious adverse events and/or safety reports:

o    Laboratory normal reference ranges (including revisions)

o    Laboratory certificate(s)

  • Section 15 – Contracts:

o       Investigator Commitment Statement/Study Acknowledgement

o       Indemnity

o       Confidentiality

o       Clinical Trial Agreement including financial details.

o       Completed and signed FDA 1572 form (if applicable)

o       Financial disclosure letter (if applicable)

  • Section 16 – Investigator’s brochure and safety alert letters/Updates
  • Section 17 – Completed data queries
  • Section 18 – Study training materials
  • Section 19 – Miscellaneous (specify)

After the completion of the trial, the following must also be filed in the site file:

  • Section 20 – Investigational product(s) accountability at site. Note: This will be with the clinical trials pharmacist.
  • Section 21 – Documentation of Investigational product destruction. Note: if destroyed at site this will be with the clinical trials pharmacist.
  • Section 22 – Final report from Investigator to REC.

Section 23 – Clinical study report to document results and interpretation of trial.

Practices should liaise with study teams about the site trial requirements for specific studies.

Where a document is amended with a new version, outdated versions should be marked ‘superseded’ and placed behind the current version in the site file.

It is the responsibility of the PI to ensure the site file is maintained. The physical maintenance of the site file may be done by a staff member delegated by the PI.

Please continue to refer to the NIHR website for current guidance related to site files, and liaise with study teams if you have study specific queries.

Glossary of Acronyms and Terms

  • NIHR – National Institute for Health Research
  • RDN – Research Delivery Network
  • GCP – Good Clinical Practice training
  • ISF – Investigator Site File (or Site File)
  • OID – Organisational Information Document
  • SIV – Site Initiation Visit
  • SOPs – Standard Operating Procedures
  • AEs – Adverse Events
  • PI – Principal Investigator
  • CI – Chief Investigator

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