E6: Trial Management, Data Handling, and Record Keeping Flashcards
Trial Management, Data Handling, and Record Keeping
5.5.1
The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
Trial Management, Data Handling, and Record Keeping
5.5.2
The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating procedures and maintain written records of all its meetings.
Trial Management, Data Handling, and Record Keeping
5.5.3
When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:
(a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e., validation).
The sponsor should base their approach to validation of such systems on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.
(b) Maintains SOPs for using these systems.
The SOPs should cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use.
(c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data (i.e., maintain an audit trail, data trail, edit trail).
(d) Maintain a security system that prevents unauthorized access to the data.
(e) Maintain a list of the individuals who are authorized to make data changes (see 4.1.5 and 4.9.3).
(f) Maintain adequate backup of the data.
(g) Safeguard the blinding, if any (e.g., maintain the blinding during data entry and processing).
Trial Management, Data Handling, and Record Keeping
5.5.4
Ensure the integrity of the data including any data that describe the context, content, and structure. This is particularly important when making changes to the computerized systems, such as software upgrades or migration of data.
Trial Management, Data Handling, and Record Keeping
5.5.5
The sponsor should use an unambiguous subject identification code (see 1.58) that allows identification of all the data reported for each subject.
Trial Management, Data Handling, and Record Keeping
5.5.6
The sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents pertaining to the trial (see 8. Essential Documents for the Conduct of a Clinical Trial).
Trial Management, Data Handling, and Record Keeping
5.5.7
The sponsor should retain all sponsor-specific essential documents in conformance with the applicable regulatory requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends to apply for approval(s).
Trial Management, Data Handling, and Record Keeping
5.5.8
If the sponsor discontinues the clinical development of an investigational product (i.e., for any or all indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific essential documents for at least 2-years after formal discontinuation or in conformance with the applicable regulatory requirement(s).
Trial Management, Data Handling, and Record Keeping
5.5.9
If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators/institutions and all the regulatory authorities.
Trial Management, Data Handling, and Record Keeping
5.5.10
Any transfer of ownership of the data should be reported to the appropriate authority(ies), as required by the applicable regulatory requirement(s).
Trial Management, Data Handling, and Record Keeping
5.5.11
The sponsor specific essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirement(s) or if needed by the sponsor.
Trial Management, Data Handling, and Record Keeping
5.5.12
The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.
