So you think you want to conduct a clinical trial? Of course, it’s a very complex undertaking. Each stage requires you to comply with regulatory and research standards. And, about a month ago NIH announced plans to improve stewardship, accountability, and transparency to build a better overall clinical trial enterprise. We expect to see a number of new guidelines, policies, and procedures in this area early in 2017.
In the meantime—for those of you currently preparing a clinical trial application or actually conducting a trial—several key documents drive both trial operations and protocol compliance. I’m pleased to let you know that NIA has a way to help you streamline study start-up and adhere to standards.
The NIA Clinical Research Study Investigator’s Toolbox provides you and your study team with a central source of materials to develop and manage high-quality clinical research studies. Templates, sample forms, guidelines, training overviews and other related information are on the site too. So you may use these materials to customize your protocol.
Why an NIA toolbox and why should you use it?
The Toolbox is one of the few such resources online. It’s widely used by the research community at large and is referenced in a number of textbooks.
The Toolbox can help you incorporate consistent processes, collect accurate data, and maintain appropriate safety oversight. It can serve as a starting point for designing your study and also as a reference in an ongoing study. We don’t require that investigators use the Toolbox materials, but we do encourage you to review, revise, and customize the documents that best support the goals of your study protocol. For example, a phase III clinical trial with a drug intervention may use most of the Toolbox documents, but a non-interventional behavioral research study would need only a portion of the materials to conduct the study.
What does the Toolbox contain?
The sections of the NIA Toolbox cover:
- Startup – templates for interventional study protocols, a manual of procedures for single- and multi-site trials, data sharing guidelines, as well as data management and recruitment tips and best practices. A multimedia safety training course provides an overview of how best to protect the safety of clinical study participants.
- Adverse Events – guidelines and sample forms for reporting requirements and processes for unanticipated problems, adverse events, and serious adverse events (yes, they are different) during the study
- Data and Safety Monitoring – reference materials for investigators and monitoring bodies responsible for human subjects oversight, including a data and safety monitoring plan and report templates
- Informed Consent – tools to develop the informed consent documents for people in a clinical study
- Study Forms – templates and outlines of case report forms (CRFs) to use when collecting clinical data. CRFs include visit forms with demographic and medical history information, as well as administrative tools for visit schedules and investigational product tracking.
A separate section contains the NIA Glossary of Clinical Research Terms. This comprehensive set of definitions for general clinical research terminology is essential reading for the whole research team involved in a clinical trial and pertains to the entire Toolbox.
NIA reviews the Toolbox each year, and new materials are added to support the changing clinical research and regulatory landscapes. If you’d like more information on the NIA Toolbox, please contact me. I’d also be very interested in getting your feedback if you have used the Toolbox contents or have suggestions to improve it.