Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data.
The recent update of ICH GCP provides new, more detailed guidelines for sponsors regarding the handling of clinical trial data, documents, and systems.
Sponsor Control of Investigator Data and Essential Documents
Essential documents are documents which individually and collectively permit evaluation of study conduct and the quality of the data produced, demonstrating compliance by the sponsor, investigator, and monitor with the standards of GCP and with applicable regulatory requirements. If these documents are not adequately managed, this could affect the credibility of the data, subject safety and overall validity of the clinical trial.
Sponsors should consider four key areas related to control of investigator data and essential documents:
- The sponsor should ensure that the investigator has control or and continuous access to the case report form (CRF) data reported to the sponsor. However, the sponsor should not have exclusive control of those data.
- The investigator or institution should have control of all essential documents and records generated by the investigator or institution before, during and after the trial.
- Essential documents for the trial should be supplemented or may be reduced, where justified, in advance of trial initiation based on the importance and relevance of the specific documents to the trial.
- The storage system used during the trial and for archiving, irrespective of the type of media used, should provide for document identification, version history, search, and retrieval.
Sponsor Responsibilities for Electronic Systems and Data Handling
The ICH GCP addendum includes updates related to the use of computerized systems in clinical trials. As you know, use of such systems has increased significantly as new technologies have been developed. An addendum to the key principles of ICH GCP makes it clear that clinical trial information, irrespective of the type of media used, must be recorded, handled and stored in a way that allows its accurate reporting, interpretation, and verification. In addition, the systems used to assure the quality of every aspect of the trial should focus on subject protection and the reliability of trial results.
Sponsors should consider the following:
- If data and records are originally recorded using temporary media, permanence should be achieved through the use of certified copies. The ICH GCP addendum defines a certified copy as a copy of the original record that has been verified, either by a dated signature or by generation through a validated process, to have the same information, including data that describe the context, content, and structure, as the original.
- Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., investigational product, trial design, data collection, and recording).
- Validation of computerized systems should include a process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based 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 the reliability of trial results.
- The approach to validation of computerized systems should be based on a risk assessment.
- Standard operating procedures should be comprehensive and include:
- System set up, installation and use
- A description of system validation and functionality testing; data collection and handling; system maintenance; system security measures; change control; data backup and recovery; contingency planning; and decommissioning.
- Responsibilities of parties with respect to use and training on the electronic systems.
The addendum to ICH GCP helps ensure the quality of clinical studies in the 21st century. Sponsors will need to incorporate these updates into the clinical trial development process, embracing a risk-adaptive approach to protecting study participants and data integrity. Are you up for the challenge?
You can learn more on this topic by reading our white paper: ICH GCP E6 (R2): A Primer for Small Biotech and Specialty Pharma Companies.