Checklists & Guidelines
IMARC Research is committed to being an industry thought leader and publishes collateral on a wide-range of clinical research topics. We welcome and encourage you to visit and download these documents for everyday use.
Checklist: Clinical Research Training Fundamentals Your Team Needs
This checklist outlines six fundamentals that should be part of the standard training for all clinical research professionals, regardless of their experience.
What Makes Good Clinical Training?
Quality training in the field of clinical research is in demand.
The market is reacting, and there are an increasing number of training programs available to research professionals. But, what constitutes effective training?
Comparing Drugs & Devices: How Are the Clinical Trials Regulated?
Follow our Drugs vs. Devices comparison guidelines to discover how the clinical trials are regulated. The regulatory requirements for conducting a clinical trial are exactly the same for drugs and devices in multiple facets, however, the differences exist in the investigational new drug regulations and the investigational device exemption regulations.
Risk-Based Monitoring: A Checklist
Is your site high-risk? Download our checklist to find out! If issues are identified during an early on-site visit, the sponsor can focus efforts on the sites that need them to obviate future risks to subject safety or data integrity. It is important to consider your level of risk when determining your monitoring approach.
Cell Therapy: The Fourth Pillar of Healthcare
Learn how cell therapy helps build the infrastructure of medicine.
Currently three main pillars of medicine exist – biologics, medical devices, and pharmaceuticals. This guide breaks down the similarities between medical device and cell therapy trials as the infrastructure begins to take shape.
Keys to Choosing a CRO
Contract Research Organization Criteria
Whether from the start, or during particular phases in your research study, choosing the right CRO to partner with can unlock the difference between approval or delays.
Good Clinical Practice Partnerships
What exactly is Good Clinical Practice?
How does GCP help protect patients and data integrity? This one page guide can help you define GCP, describe what makes up GCP, and ultimately remind you that the responsibility for clinical research ethics rests on all of our shoulders.
IRB + 1 2 3 = Patient Protection
Understanding Institutional Review Boards
The Code of Federal Regulations outlines specific requirements for conducting clinical studies. 21 CFR 56 describes the responsibilities of Institutional Review Boards (IRBs), also referred to as Ethics Committees. In this guide, we share the 3 IRB requirements to ensure patient protection.
ALCOA Checklist
If it wasn't documented, it wasn't done
"ALCOA" remains the practice of FDA auditors and quality assurance professionals regarding clinical practices to properly document your work.
