"Conducting Clinical Trials A-Z"

Pre-Award & Study Initiation

Sponsors and their representatives may seek out an investigator directly or they may approach the UKCRO to identify a suitable investigator.  Once an investigator is identified and interested, we then notify the sponsor and coordinate the confidentiality agreement (CDA) and if needed assist with the investigator questionnaires so that paperwork flows quickly to and from.

Feasibility Assessment                                            

Upon receiving the protocol, the investigator can review and determine whether the study merits participation and whether the site has the appropriate resources to successfully conduct the study.  This review is referred to as a feasibility analysis.

Feasibility assessment involves considering all of the elements affecting your decision to accept a trial.   The Feasibility Checklist provides points to consider regarding site enrollment potential, study protocol, and requirements including staff, facility, equipment and supplies.

If overall evaluation leads you to reject a trial – tell the sponsor that you did a careful assessment and decline but are open to future opportunities.  They will appreciate your candor and diligence and would certainly favor your site over one that accepted a trial and failed to recruit or complete the study.

Feasibility Checklist (PDF)

Site selection – What The Sponsor Is Looking For:  

Clinical research sites should provide objective documentation to support their ability to efficiently and accurately conduct a trial within the sponsor requirements.   Once a sponsor/CRO shows interest in a site, they may request that the site compete a Investigator Profile or Site Assessment and/or schedule a pre-study site selection visit to evaluate the site in person.

Before the Pre-Study site visit

• Carefully review the Site Selection Checklist (PDF) for assessment criteria and responses to common sponsor questions.

• Request from the sponsor several potential meeting dates and times to accommodate as many key personnel as possible.

• Ensure that these team members will be available and have allocated sufficient time for the meeting date established with the sponsore.

• Ensure that key site personnel receive copies of the protocol, investigator’s brochure, and any other study materials for review and comment.

• Ensure that the appointment with the sponsor is confirmed. Provide directions to the investigative site.

• Provide the UK CenterWatch Profile web address to familiarize them with the institution, area and provide suggestions for hotels and restaurants.

Site Selection Checklist (PDF)

During the Pre-Study site visit the sponsor will likely provide an overview of the trial, their expectations and the site qualifications. Use the opportunity to make requests of the sponsor as well including:

• Information on the anticipated time line for the study

• Request that the sponsor notify the site in writing if selected

• Sponsor chain of command and communication plan

• Potential publications

• Information on key dates, such as Investigators’ meeting and/or Study initiation meeting, Study drug availability, etc.

• Any available electronic copies of study documents (protocol, consent form template, contract, etc)

Investigator Start Up Meeting

One of the responsibilities of sponsors is to train appropriate investigators.  The investigator start up meeting is a primary means to accomplish this. Unless done via teleconference, the meetings typically involve travel to a single location where the sponsor can present the study to many investigators (and coordinators) at once to efficiently cover material, provide hands-on training, and address questions or concerns that may result in protocol modifications. Usually a sponsor will require an investigator (PI or Sub) to attend and one coordinator.

You should inquire if the sponsor will cover all travel cost associated with attending the meeting.   It may be worth requesting that an additional coordinator that might provide coverage for the study attend.  Some sponsors may agree to the additional cost as it would save future cost of re-training in the event of coordinator turn over.   In addition to learning about the trial, use the meeting to meet sponsor or CRO staff that you will be working with on the current trial and network to market your site for future studies.  Bring your business cards, brochures etc to build professional contacts.