When thinking about clinical trial documentation compliance, 21 CFR Part 11 usually comes to mind. For those unfamiliar with the Code of Federal Regulations designation, 21 CFR Part 11 provides criteria for electronic records, electronic signatures and handwritten signatures applied to electronic records. However, the criteria covered in 21 CFR Part 11 are not the only requirements that should be considered for compliant document management associated with clinical trials. Multiple other regulations require maintenance of general and trial-specific documents in regards to human subjects protection (45 CFR 46, 21 CFR 56, and 21 CFR 50), privacy and security (HIPAA, 45 CFR 160 and 45 CFR 164), financial disclosure of clinical investigators (21 CFR 54), new drug development (21 CFR 312), and device development (21 CFR 812).
Regardless of whether you are a sponsor or an investigative site, it is imperative that you have a reliable system and associated policies for storage and upkeep of documents surrounding trial conduct.
Consider document management at an organizational level
When seeking approval for a new drug/biologic/vaccine/device, you’re required to provide documentation associated with the progressing development of that new treatment, including regulatory documents, protocols, agent documentation, contracts, source documents, case report forms and numerous other documents from pre-clinical and clinical trials. Together, these documents make up the Trial Master File (TMF), which is used by the approving agency (FDA in the U.S.) to ensure complete information is present during the review process.
Due to the extent of the TMFs, and to comply with the regulations listed above, it’s also necessary to document many different infrastructure items needed to conduct ethical and compliant research. Items like: IRB rosters, IRB review documents, financial disclosures, training of individuals involved in the conduct of research, signed informed consent forms, drug receipt/disposition records, policies and procedures, etc. Many of these items surpass the level of a single study, or even a single treatment pipeline. Thus, it is important to consider how such documents will be stored and managed at an organizational level. This is done in two ways: processes and systems.
Implement effective processes and systems
Organizations should have centralized policies on how required documents are to be kept. These policies should discuss:
- How documents should be stored and made accessible while they are still considered active
- Designate the responsible party for records retention
- How and when to archive documents (NIH, FDA, and HIPAA regulations all differ and may not be the only ones that must be considered)
- How long to store documents once archived
- Describe a process for dispersion of documents that have expired
The other aspect of the organizational maintenance of documents is the system. While it is possible to store paper copies of all necessary documents, this comes with considerable cost and effort to ensure they are kept in a safe and orderly fashion. This also requires duplication of documents to ensure all files have every required/necessary document. For example, let’s say that our investigator has five clinical trials. For each of those trials, we have several shared documents, including the investigator’s CV, training certificates (e.g. human subjects training, HIPAA, etc.), conflict of interest disclosures, and medical license. Anytime any of these documents are updated, all five trials must be updated. Depending on the system in place, if documents are not consistently maintained, this can be a source of a large number of regulatory deviations.
The Office of Human Research Protections (OHRP), the Office of Civil Rights (OCR), the FDA, as well as other regulatory authorities, have stated it is appropriate to store documents electronically with proper safeguards, such as security and encryption. Should you choose to electronically store and maintain these documents, it is imperative to consider several items, such as chain of custody, audit trails for changes, security to ensure that electronic signatures are from the intended signee, electronic storage and backup requirements/options, and accessibility.
Choose the right system to increase compliance and productivity
Use of an electronic system does not automatically remove the issues associated with paper systems. Policy regarding scans of wet signatures and whether those scans can be considered “original” (i.e. can you throw away the paper copy) are necessary. Electronic systems can be created that are essentially a glorified Windows Explorer file system. If a system such as this is used, you must consider processes on how to update multiple copies of the same document in different locations (e.g. study “binders”/folders, with different departments/compliance units) in addition to the security concerns/access issues.
More sophisticated systems, such as Forte’s eRegulatory Management System, help organizations manage documents in an easy and compliant manner. These systems have technical controls necessary to validate the system to be part 11 compliant along with an organization’s policies and processes; have access restrictions to allow only authorized personnel access to specific documents; and have methods in place to disseminate updated documents to different locations, ensuring compliance across multiple studies. Such an approach will ease the burden of the researcher, study staff, and compliance units across an entire organization. This will decrease deviations associated with documentation errors and improve efficiencies associated with study monitoring and compliance auditing.
Learn more about Forte eReg
Forte eReg boosts compliance and productivity with workflows designed specifically for organizations focused on regulatory compliance across their entire clinical research portfolio. The system was developed through collaboration with industry-leading academic centers, creating unique efficiencies enterprise-wide. With 21 CFR Part 11-compliant electronic signatures, master delegation of authority workflows, efficient remote monitoring and more, Forte eReg provides a comprehensive solution to streamline your regulatory management.
To learn more, watch our on-demand webinar, Steps to Overcome Your Biggest Regulatory Challenges. We discuss how to overcome delays in study startup, overworked regulatory staff, soaring costs and more. We also provide a short demo of Forte eReg, highlighting how the system can help address these challenges.