Preparing for a Clinical Trial

A Summary of Best Practices

Preparing for a Clinical Trial Photo by Johny Georgiadis on Unsplash

Preparing for a clinical trial begins in sponsorship and ethics applications. All clinical trials must have sponsors and meet ethical standards prior to commencements. The clinical trial preparation links many areas with sponsorship such as through budgeting a human resources, and participant recruiting. The following list provides a basic overview of the clinical trial preparation:

1. Sponsorship and Ethics Applications
2. Risk Assessment
3. Specific Funding Requirements
4. Sourcing the Investigational Medicinal Product (IMP)
5. EudraCT Number
6. Clinical Trials Authorisation (CTA)
7. Protocol registration
8. Agreements
9. Delegation of Sponsor Functions
10. Delegation within the Study Team
11. Trial Master File
12. Data Management and Case Report Form design
13. Training (University of Oxford, 2015)

This is a large list but most importantly what this list covers is the large area of paperwork that is required prior to commencing a clinical trial. For instance, EudraCT Number is the registration that is required for performing a trial in the European Community (University of Oxford, 2015). Likewise, specific types of studies must be authorized which means the investigator needs to obtain CTA (University of Oxford, 2015). Much of these steps or focused on the administrative requirements of the clinical trial to make sure that it is ethical and legal in compliance.

Perhaps one of the most important aspect of the preparation process is the budget. The budget preparation process is intrinsically linked with other steps in the preparation process such as identifying study personnel and their salary requirements. Similarly, members must often be selected for a budgeting team. These individuals will be adept at identifying the costs associated with the budget. The budget is also tied in with subject or participant selection.

Participant standard and requirements must be made in consideration of the budget because the participants will cost the trial money. These costs come in a number of ways whether from paying participants or the cost of care during the trial. These considerations must be included in the budget preparation.

While it may seem like the budget overshadows most of the clinical trial preparation, this is not totally true. The budget is just linked with all aspects of the trial because it governs its operations. For this reason, preparation for the clinical trial must deal with budget issues.

References

University of Oxford. (2015). Clinical Trial (CTIMP) Preparation. Retrieved from Research Support: https://www.admin.ox.ac.uk/researchsupport/ctrg/classification/trialprep/#d.en.123957

~Citation~

Vincent Triola. Mon, Feb 01, 2021. Preparing for a Clinical Trial Retrieved from https://vincenttriola.com/blogs/ten-years-of-academic-writing/preparing-for-a-clinical-trial

Need similar articles?

Clinical Research