Investigator File and Overall Study Documentation

Access guides on managing investigator files and study records. Download articles covering documentation, audits, and study closeout from the Chicken Soup Series.

Last updated on 7 August 2026

Chicken Soup Series - Investigator File and Overall Study Documentation

(Apr 2025) Preventing Information Discrepancies between IRB Application Form & Study Documents (opens in new tab)
(Jan 2025) Study Audit or Inspection – The Activities Involved Before, During and After (opens in new tab)
(Mar 2024) What You Should Know About Documentation & 'Certified True Copies' (opens in new tab)
(Sep 2023) What Should Be Done When a Study Is Completed? (opens in new tab)
(Sep 2022) Electronic Filing of Essential Documents (opens in new tab)
(May 2021) How to Prepare for a Study Review or Audit? (opens in new tab)
(Feb 2021) Investigator Site File (ISF) Management (opens in new tab)
(Feb 2020) How to Ensure Consistency of Study Documents Throughout the Duration of the Research (opens in new tab)
(Apr 2019) Essential Documents - Setting Up and Maintaining the Investigator File (opens in new tab)
(Mar 2016) Declaration, Submission & Filing of the Financial Conflict of Interest Declaration Form (opens in new tab)
(Jan 2016) How Research Misconduct Impacts the Principal Investigator, the Research Team and the Study (opens in new tab)

_DISCLAIMER_{: Past Issues/Articles may contain best practices, policies or SOPs that have been superseded or may no longer relevant or applicable. For NHG Health and partner institutions, we encourage you to refer to the latest NHG Health PCR SOPs (available via NHG Health Intranet access or Partner Institution’s CRU/Research office). Always refer to your own institution’s latest policy, SOPs, guidance documents and templates.}