Clinical studies cannot be successful without proper documentation, strict adherence to regulatory requirements, and the ability to demonstrate conformity to good clinical practice (GCP). What are the essential documents in clinical trials and research, and what do clinical trial sponsors need to know to stay compliant?
These rigorous requirements are essential to product life cycle management in pharma and apply to any company that intends to develop drugs and test them on human subjects – regardless of whether the research is conducted at big vs small pharmaceutical companies.
Let’s dive in and discuss some essential recordkeeping elements in clinical trials.
You can design better clinical trials when you have better insights.
What is the regulatory binder?
FDA-regulated research is required to conform to CGP standards, which define the essential documents that trial investigators are responsible for creating and maintaining. Collectively, these key documents are referred to as the regulatory binder.
Other names for the regulatory binder include:
- Clinical study files
- Investigator files
- Investigator binder
While the name of the regulatory binder seems to indicate a physical binder containing hard copies of various documents, investigators can choose the most appropriate way to fulfill these record-keeping requirements. Whatever format it takes, the regulatory binder and all associated essential documents are reviewed during routine study monitoring.
What are the essential documents in clinical research?
In clinical research, essential documents are defined as documents that “individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.” Not all essential documents will be available at the beginning of a study, and not all documents have to be stored in the same location – though trial sponsors must know where various documents are stored and how to retrieve them when needed.
Key documents include:
- Site visit (monitoring) log that provides documentation at the site where the study was monitored, and the frequency of monitoring.
- Delegation of authority (responsibilities) log to document the responsibilities assigned to research team members and when they were involved in the study.
- Site personnel signature log
- Study staff education to prove people involved with the study have completed any required training
- Curricula vitae, financial disclosures, investigator statements
- Public registration of research studies (PRS), if applicable
- Participant screening and enrollment log
- Participant visit tracking log
- Trial subject identification code list
- Informed consent forms, in reverse chronological order (includes HIPAA forms)
- Study protocol and all amendments in reverse chronological order
- IRB federal wide assurance letter
- IRB approvals and communications
- Investigational product information, as applicable, including investigator’s brochure, package insert, and device manual
- Study termination
- Protocol deviations and exceptions
- Adverse events and unanticipated problems
- IND safety reports
- Advertising or educational materials, if applicable
- Sample tracking and shipping, if appropriate
- Temperature logs for refrigerator and/or freezer
- Investigational/test article
- Local lab certificates/reference ranges
- Blank set of case report forms
- Trial master file and other trial-related materials
- Source documents
Why are these documents needed for clinical trials?
Essential documentation demonstrates compliance with GCP standards and all applicable regulatory requirements. For trial sponsors, filing essential documents in a timely fashion can assist in successfully managing a clinical study.
How does insights management technology support clinical teams?
Some of the latest trends in pharmaceutical innovation revolve around how companies can work more efficiently and bring treatments to market more quickly while staying compliant. However, many elements of clinical research and clinical investigation have long timelines by design to ensure efficacy and safety. What innovations can trial sponsors pursue to reveal efficiencies within their operations?
Trial teams may use technology, such as an insights management platform, to support various clinical development and operations aspects. While essential documents like those described above are not stored or originated in an insights management platform, trial teams may conduct required training within the platform, develop study protocols with global stakeholders, engage patients throughout or following a trial, or develop publications based on findings from a study. Conducting these conversations and activities with a secure platform can ensure compliance during the drug development regulatory process.
Download our free ebook to learn more about how an insights management platform supports trial teams.