Being a trial site

Being a Trial Site

Being part of clinical trials can be a rewarding part of medicine. While it does take some effort, it potentially provides you and your patients with access to novel treatments and methods. It is also a great way to learn about the research process and offers the opportunity to collaborate with peers. The skills and systems you develop from trial participation can even help you in planning your own studies.

Before becoming a trial site it is important to be aware of what you and your site will require. We have presented a summary of the requirements below. Remember that trial investigators will always be willing to problem solve if it means a motivated site joins their study – so if you don’t have all of the following items in place it is still worth expressing interest as others may be able to help you to get your site ready to go.

To become a trial site, you should have:

A leader – Principal investigator

A team – which might include co-investigator(s), study coordinators, a pharmacist and/or study-nurse(s)

Good Clinical Practice (GCP) training and certificates for all trial site staff

Basic equipment for handling drugs and laboratory specimens – centrifuge, refrigerator(s) etc.

Access to local laboratory, radiology and/or pharmacy services

An appropriate place for study documentation storage, for Investigational Medicinal Product (IMP) (i.e. the study drug) storage and dispensing

Appropriate place to see the patients and administer the treatment

Access to the internet

Enough time to conduct the trial (it may be more time-consuming than you first think)

For international trials, sufficient English or support from a translator to understand the Protocol and Investigators Brochure and Manuals, communicate with Contract Research Organization (CRO) and Study Team, and manage the electronic Case Report Forms (eCRF) (all trial site staff)

Starting as a trial site - once you are approached by the study team, you will have to:

  • Review the study protocol, especially the site and patient eligibility criteria. Your aim here is to consider whether you have sufficient patients that would meet the study eligibility criteria and the resources to conduct the study
  • Make sure you have sufficient staff, room and equipment to conduct the study
  • Make sure that the specific patient population is available in your institution, or you have contacts with other institutions which can refer the patients
  • Make sure you are able to follow the screening and recruitment schedule, and study protocol procedures
  • Make sure your institution has an appropriate license for all procedures outlined in the study protocol
  • Make sure you have an access to an accredited Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
  • Make sure the head of your institution will sign the Study Agreement
  • Consider if the financial or other support provided by the study sponsor is sufficient to cover the costs of running the study at your site

Once you are a trial site, you have to be ready to:

  • Undergo specific training, most of which is online
  • Receive and manage multiple correspondence from the monitors and study team
  • Receive and manage multiple protocol versions and amendments
  • Spend time talking to the patients about the trial before they sign Informed Consent
  • Expect challenges in pre-screening and screening patients – it may be harder than anticipated to find eligible patients
  • Timely obtain, handle and ship samples from the patients
  • Monitor and timely report Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Undergo monitor’s visits – which may not happen as often as you need
  • Be audited