Closing a Clinical Trial Summary
Closing a clinical trial begins in the start up phase in so far as planning is concerned. The proper closing of a study encompasses several best practices for making sure that:
…the site investigator’s study obligations have been met and post study obligations are understood. Closeout activities verify that study procedures have been completed, data collected, and if relevant, study intervention is returned to the responsible party or prepared for destruction (Dinnet, Mungall, Kent, Ronald, & Gaw, 2004).
While the procedures for closeout may vary by site there are number of similar steps that must be undertaken in order to create a proper close out. The following steps reflect this common approach:
1. Study Forms- preparation and proper collection of all case reports, data, SAEs, and audits have been organized and secured. This would include any number of files and documents such as:
a. Curriculum Vitae(s) (CVs), Investigator’s Brochure(s)
b. IRB approval letters for the protocol, all amendments, Informed Consents, annual reviews and advertisements (including updated approvals)
c. All IRB correspondence
d. Site signature log
e. Drug accountability records
f. All informed consents are signed and on file (Dinnet, Mungall, Kent, Ronald, & Gaw, 2004).
2. Clinical Supplies- the disposing or shipping of supplies and equipment according to protocols.
3. Laboratory Records and Specimen Retention are sent to the appropriate labs and documented properly.
4. Final Report to the IRB stating what was documented and where supplies and equipment were sent or disposed of.
5. Participant Rights and Notifications letting the participants know the findings, reason for closing of study and treatment of options (Dinnet, Mungall, Kent, Ronald, & Gaw, 2004).
The closing of a clinical trial should follow this type of protocol whether it was closed early or on time. These protocols represent the best clinical practices for accountability and for safety. They also present the best means of maintaining credibility with data and findings.
Dinnet, E. M., Mungall, M., Kent, J. A., Ronald, E. S., & Gaw, A. (2004). Closing out a large clinical trial: lessons from the prospective study of pravastatin in the elderly at risk (PROSPER). Clinical Trials, 1(6), 545–52.