Study Files and Filing - Clinical Trials

A Study File may consist of more than one distinct file. Too many different files should be avoided. It is usually unnecessary that each individual patient has a separate file. The Investigator’s Brochure may also need to be located separately; if so, the Study File should indicate where. Each patient’s informed consent form should be filed in the patient’s medical notes.

The Study File will be sub-divided. For example:

• Correspondence.
• Protocol and Amendments.
• Investigator’s Brochure.
• Drug accountability.
• Ethics Committee.
• List of patients entered (to enable easy identification of individuals in the future. The list should also include those actively considered for the trial but not entered, with reasons for non-entry where appropriate).
• Code envelopes may be stored in the Study File, but may be stored separately, e.g. at Pharmacy. The location should be recorded.
• Where required, registration of clinical trial with the regulatory authorities and/or local management.
• Completed serious adverse event forms (if not included in the CRFs).
• Financial agreement, unless stored elsewhere.
• Records of telephone conversations and notes of study meetings should also be filed.
• The Sponsor will also keep records of telephone conversations and make written reports after each visit. During an audit, these records will be checked for consistency.
• Completed consent forms (or copies).
• Study-specific SOP checklists.
• The completed CRFs will usually be stored in a separate file.