Building a Successful Research Centre
There are many steps involved in adding a successful, recognized diabetes research program to your clinic.
Research Team Members
A research team is made up of many different healthcare professionals who come together to support clinical research and its participants. Some of the professionals that may be involved are listed below:
Principal Investigator (PI)
The principal investigator is the leader of the team of individual researchers at a clinical trial site and is ultimately responsible for the conduct of the clinical trial. This is typically a physician.
The sub-investigator is also a researcher at a clinical trial site but is designated and supervised by the principal investigator at a trial site to perform critical trial-related procedures (for example, complete a physical exam on a subject) and/or to make important trial-related decisions (for example, assess severity and causality of any adverse events reported). There can be none or many sub-investigators involved in a research trial.
Clinical Research Coordinator (CRC)
The clinical research coordinator works under the immediate direction of the investigators. They process study subject visits and conduct activities that fall under the good clinical practice guidelines. This can be any registered health care professional that has completed all trial and research related training at least on a basic level.
- Certified Clinical Research Coordinator: is a formal designation that identifies that individual as meeting the professional standards set forth by an agency responsible for this credentialing process of a clinical research coordinator. In Canada, the Clinical Research Association of Canada is responsible for recognition of this certification. Please find more information here.
A research assistant is part of the research team but may or may not have professional training in research conduct. The scope of work usually involves clerical duties and works under the immediate direction of the clinical research coordinator assisting in various task associated with the conduct of the research trial.
Medical Laboratory Technologist
Medical laboratory technologists are responsible for performing various research trial specific tests and procedures to obtain, process, analyze and report specimen and laboratory samples as required by study protocol.
The Role of the Sponsor
The sponsor is responsible for providing funding for the research study. This can be done through industry-funded initiatives, government, and other public sectors (for example, post-secondary institutions). The sponsor is responsible for:
- Assessing investigator and site qualifications
- Providing the site with an Investigator Brochure (IB) that describes all the background information about the investigational drug to date
- Site protocol training, management and compliance and deciding the site plan
- Providing the site with a clinical trial agreement and financial compensation as agreed upon by the PI and Sponsor.
- Providing the protocol, related and regulatory documents (for example, recruitment material, safety reports, continuing reviews, amendments FDA 1571 Form, annual reports and final reports)
- Conducting sponsor investigational product accountability and drug destruction, as needed
- Maintenance and retention of essential study related documents
- Developing, verifying, and maintaining study related data from site to electronic databases for review and analysis.
- Monitoring including study coordination, record verification, and quality assurance. This feedback must be provided to the site in written format and verbally reviewed including any corrective action plans needed
- Provide ongoing support to the site as needed.
Research Team Training and Education
Study Related Training
Training and education of all research staff is provided by the sponsor for the following areas: study protocol, investigational product, scope of their role in the study, obtaining informed consent, a review of eligibility criteria, enrolling and randomizing patients with study codes, processes for drug handling and dispensing, adverse event reporting, data management and reporting requirements, technical complaints management, and any other specialized training modules provided by the sponsor.
Standard Operating Procedures (SOPs)
SOPs are often required by the sponsor and are detailed, written instructions to provide a description of the sites specific procedures. SOPs are put in place to protect the safety and confidentiality of study participants. They are specific to the research site and are not only critical to a research site’s quality performance but also ethical conduct. The research manager must routinely update and modify the SOPs in order to stay current.
Training on the Responsible Conduct of Research
This training is not specific to a study protocol but is applicable to all research trials. It is important that the research team be familiar with the information provided in the following links:
An organization should develop a means of data collection, transfer, storage and access for all data collected in a clinical research study. This method should be comprehensive, secure, and relevant to the study requirements. It should also support confidentiality and be completed in a timely manner. Some ways you may do this include keeping participant binders, having a research space with limited access, or by keeping restricted electronic files.
Quality Assurance and Improvement
In addition to the monitoring and evaluation of study conduct by the sponsor, each organization should have a quality assurance and improvement program within the centre. For example, an organization can choose to annually review by random selection a minimum of 10% of patient records to assess accuracy of your team’s documentation, protocol adherence, and regulatory requirements. Access to an independent form of quality assurance or service is also an option. Furthermore, the research centre team will evaluate subject research experience to improve the research experience for future participants and study visits.
The organization needs to be prepared for study sponsor-initiated audits or Health Canada requested audits at any time. These audits are a large, systematic and independent evaluation of research study activities according to the study protocol, Standard Operating Procedures (SOPs), good clinical practice (GCP), and regulatory requirements.