The study close-out activities of a clinical research protocol are as important to complete as the initial approval and study start up process. At the completion of the study the Principal Investigator is responsible for ensuring the appropriate close-out activities are completed and the proper institutional offices are notified.
Trials conducted at Temple University can be considered closed and proper notification sent out when:
Subjects have completed their final visit and all follow up data has been collected AND
All data analysis is completed at the site. AND
For Industry funded Trials:
As above AND the Investigator has been notified in writing by the sponsor or sponsor representatives that the site can be closed. A copy of this letter must be maintained in the regulatory file at the Investigative Site.
During the Close out of a trial the Principal Investigator responsibilities include:
Completion of Study Records
Reconciliation and Inventory of Study Supplies
Notify Institutional Regulatory Offices (IRB and other oversight offices specific to the project)
Report changes in Conflict of Interest/Financial Disclosure (if applicable)
Publication and Presentation of Trial Results
Proper Record Retention of Study Documentation
Completion of Study Records
The Investigator and their staff must ensure all data collection is complete and accurate to permit proper statistical analysis and evaluation of the study results. It is important that study data be entered into the Case Report Forms (CRF's)/Data Collection Tools as soon as possible after the subject visit and proper source documents are completed to facilitate efficient and timely data management.
As a best practice, but especially for multi-center trials during the course of the study the data is evaulated in a blinded fashion (if applicable) and data edit checks are performed by a data coordinating center to standardize certain aspects of the data. This data management process is completed during the conduct of the study and more intensely at the conclusion of the study. The Investigator is responsible for resolving any data edit checks, commonly referred to as "Data Queries" in a timely and accurate manner. The completion of the data query process permits the study database to be truly finalized and ready for data analysis.
Reconciliation and inventory of Study Supplies
The reconciliation and Inventory of the Investigational Product, additional study supplies (i.e. laboratory supplies etc) and the proper retention of study records are priority when completing a clinical trial. For Industry sponsored clinical trials the sponsor will determine the disposition of the remaining inventory of the study drug, device, and supplies.
Reconciling the Investigational Product
The Investigational Product will either be returned or destroyed at the conclusion of the study. Tthe reconciliation of the Investigational Product must be properly documented and retained. The research staff should document the following Information.
Identifying Information (lot, batch, or serial numbers)
Quantity of drug or device used and unused
Shipping Information (for returned drugs or devices)
Means of Drug or device destruction and person responsible for destruction
Date of drug or device destruction (see below)
The return or destruction of the Investigational Product should be consistent with the sponsor's Operating Procedures and the Sponsor developed form should be utilized at the time of reconciliation.
Notify Regulatory Offices (Institutional Review Board and other oversight offices specific to the project)
Institutional Review Board
The Institutional Review Board (IRB) will consider a study open and reporting is required until the study closure report is received by the IRB. The study closure report can be submitted to the IRB when:
all subjects have completed their final visit and all follow up data has been collected
all data analysis at the site is completed
for industry funded trials when the site has been notified by the sponsor or sponsor representative that the site can be closed.
The Investigator must use proper reporting procedures for the Institutional Review Board that has approved the trial.
Temple Institutional Review Board - To close out a trial with the Temple IRB the Investigator must:
Prepare a Memo that provides the following general elements of a study closure report include the date the study is closed, final recruitment and retention figures, final report of safety events (specifically Serious Adverse Events), Summary of trial outcomes at Temple.
Fox Chase Cancer Center Institutional Review Board- The Fox Chase IRB requests a final report to the IRB that includes the date of termination, reason for termination, completion date of the project: if not completed give the reason, list of any unforeseen adverse effects, results, publication of results. For additional information visit the Fox Chase IRB Policies Manual.
Investigators are required to submit ALL interim and ongoing communications to the IRB until the STUDY CLOSURE NOTIFICATION has been provided to the IRB. This includes but is not limited to Safety Reports, Interim/Re-Approval/Study Progress Reports, Protocol or Consent form Amendments, and other relevant IRB Communications about the conduct of the trial.
Investigators must also report any changes in Financial Disclosure or Conflict of interest at this time. If this is a clinical trial conducted under an Investigational New Drug Application The Food and Drug Administration requires updates to Financial Disclosure during the course of the project and up to 1 year after the conclusion of the project.
Additional Offices for Regulatory Reporting
Additional Committee's or offices that reviewed and approved the project should be notified of study completion. This includes the Medical Radiation Committee, Pharmacy and Therapeutics, Institutional Biosafety Committe and the GCRC. A copy of the Institutional Review Board memo can accomplish this task.
Notify Financial Administrative Offices
For Industry Funded Clinical Trials notify the Office of Clinical Trials and your department administator to confirm the completion of your trial. The Office of Clinical Trials can assist with reconciliation of your Budget and can also take the clinical trial listing down from the Office of Clinical Trials Web-site. The Office of Clinical Trials has developed a study close-out report that you can use to report your study close to the IRB and to the Office of Clinical Trials.
For non-industry funded trials please notify and seek guidance from your Department Administrator and Sponsored Projects of the completion of your study grant.
Report changes in Conflict of Interest/Financial Disclosure (if applicable)
Each Investigator is responsible for updating changes of Significant Financial of Interest during the course of the Project. If this is a clinical trial conducted under an Investigational New Drug Application The Food and Drug Administration requires updates to Financial Disclosure during the course of the project and up to 1 year after the conclusion of the project.
If you need to report a change in your financial conflict of interest submit a new Institutional Conflict of Interest Disclosure Report to the Sponsored Projects Office and to the Insitutional Review Board.
