Investigator File and Overall Study Documentation

Chicken Soup Series - Investigator File and Overall Study Documentation

• (Mar 2024) What You Should Know About Documentation & 'Certified True Copies'

• (Sep 2023) What Should Be Done When a Study Is Completed?

• (Sep 2022) Electronic Filing of Essential Documents

• (May 2021) How to Prepare for a Study Review or Audit?

• (Feb 2021) Investigator Site File (ISF) Management

• (Feb 2020) How to Ensure Consistency of Study Documents Throughout the Duration of the Research

• (Apr 2019) Essential Documents - Setting Up and Maintaining the Investigator File

• (Mar 2016) Declaration, Submission & Filing of the Financial Conflict of Interest Declaration Form

• (Jan 2016) How Research Misconduct Impacts the Principal Investigator, the Research Team and the Study

_{DISCLAIMER: Past Issues/Articles may contain best practices, policies or SOPs that have been superseded or may no longer relevant or applicable.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