Table of Contents
How do I choose a clinical trial site?
Selecting Study-Appropriate Clinical Sites in 3 Steps
- Step 1: Define Site Requirements and Selection Criteria.
- Step 2: Identify Sites and Gather Initial Information.
- Step 3: Evaluate and Select the Sites.
How do I choose a study site?
Site selection criteria for efficacy trials focus on qualifications, experience and reputation of the investigator; availability of local patients, labs, data about the patient population, and presence and quality of the local Institutional Review Board (IRB) [1]; prevalence and incidence of the disorder to be studied …
What is site identification?
During site identification, use available information to identify suspect sites for further investigation, or to rule out sites that are not contaminated. If a site is not contaminated, then no action is required. If contamination is suspected at a site, then further investigation through Step 2 is required.
What components should always be included in a well designed clinical trial?
A clinical trial design must define the main criteria: type of study (including duration and randomization of volunteers in assigning them either the treatment or the control), patient population, exclusion and inclusion of a volunteer in the clinical trial, safety, and efficacy end points.
What is a clinical site?
A clinical research site is a location, be it a brick-and-mortar facility in a city or a tent in a village in the bush of a developing country, committed to human subject projection and the ethical conduct of clinical research, which produces quality data to enable a scientific decision on the safety and efficacy of an …
What is routine site monitoring what are the activities conducted by a CRA at the site during the monitoring visit?
CONDUCTING THE SITE MONITORING VISIT During a monitoring visit, the CRA will review specific data and regulatory documents related to the clinical protocol, as described in this section, and verify signed consent forms for each study subject.
What makes a clinical trial?
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.
How can we improve the quality of clinical trials?
In order to prevent these effects, trial organizers must ensure that potential sites are carefully screened and only those which are equipped and able to recruit patients and collect accurate, high-quality data are eventually selected. This will increase the likelihood of a trial that is both timely and cost-effective.
Can your site meet the requirements of a clinical trial?
The only way to truly be sure the site can meet the requirements of the trial is to ensure it has previously been involved in a study of a similar size or complexity. Recruitment statistics for previous trials, if available, are also a great indicator of expected performance and should be compared to the estimates the site has provided.
What is ‘careful consideration’ in clinical trials?
Careful consideration is essential for several ethical and operational reasons, and so research sites must take care in comprising clinical protocol that fits the needs of their investors. Sites considered ‘inadequate’ by clinical trial sponsors could ultimately drain valuable resources through the extra training and the costs incurred by delays.
What do Cros look for in a clinical trial site?
While these issues are down to a variety of factors, including a stigmatization of – and general disinterest in – clinical research, CROs and clinical trial sponsors look for research sites who can prove that they can successfully enroll, treat and evaluate participants.