The Difference Between Academic and Private Industry Clinical Trials

One way to remember the difference between an academic and private research site is that private research sites do not develop their own protocols. Private research sites obtain their protocols from sponsors.

Unlike academic research, private research does not begin by writing a grant proposal.

Can A Research Clinic Keep Source Documents At A Different Facility During A Clinical Trial?

Having source documents in multiple locations is not a common practice however, is allowed by most sponsors. One major caveat is that both locations must be mentioned on the form FDA 1572.

Establish logs or documents that track your source documents as they change locations.

Establish logs or documents that track your source documents as they change locations.

Items Research Clinics Usually Overlook When Negotiating Clinical Trial Budgets

The negotiation process must be able to account for all services and procedures that occur during the course of the study. Because of how challenging this process can be, many items can easily be overlooked.

Not adding certain items to a budget during negotiation is a very common mistake.

Not taking every chargeable item into consideration during budget negotiations, is a very common mistake.

What Is The Regulatory Startup Process In A Clinical Research Study?

The Institutional Review Board (IRB) will always focus on subject safety. This video describes the requisites for a successful IRB approval process.

Always use a central IRB!

Always use a central IRB!

What Are Some Day To Day CRA and Research Site Tasks In Clinical Research?

Many people are interested in the various functions of a typical Clinical Research Associate (CRA). Some of the responsibilities of a CRA revolve around monitoring patient safety, Investigational Product (IP) accountability, and interacting with study staff at different research sites.

 

Monitoring letters are one of the most useful tools a CRA can use. The original letter is usually sent to a research site by mail, but electronic versions are generated and also shared with the site.

Monitoring letters are one of the most useful tools a CRA can use. The original letter is usually sent to a research site by mail, but electronic versions are generated and also shared with the site.

What Clinical Trial Leaders Are Doing To Improve Patient Recruitment and Retention


 

In this video I discuss clinical research participant retention and recruitment. Factors such as transportation, appointment reminders, and studies that are concerned with a subject’s well being.

Be aware that an IRB can consider things, such as transportation, as coercion

Be aware that an IRB can consider things, such as transportation, as coercion