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Dear Nova Scotia Health clinical trials community,
Welcome to the second edition of the Clinical Trial Newsletter! We hope the newsletter is helpful and informative. We would love to hear from you! If you have comments or have suggestions for future editions, please email [email protected]
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Human Research Protection Program:
The Human Research Protection Program (HRPP) is an institution-wide review and education process for research, conducted to ensure the protection of research participants' rights and welfare through an organization-wide review, education, surveillance and engagement process.
For further information on HRPP:
Please contact [email protected] if you require CE credit/certificates for these sessions.
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Regulations and Standards | |
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Medical device research:
Confused about the regulations that pertain to medical devices used in clinical research? You’re not alone. Join Presenter Dr. Ashish Indani, Senior Manager of Clinical Affairs at Stryker in his presentation “Comparing Clinical Research Regulations for Medical Devices”
Date: Wednesday November 9, 2022
Time: 10:30 a.m. - 12:00 p.m. (please note the time – Dr. Indani is located in India)
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TCPS
The Tri-Council Policy Statement is the basis for all REB guidelines and standards and was updated in 2018. REMINDER: This means PIs, Sub-Is, and all research team members will have to certify or re-certify on the new TCPS2 CORE tutorial by December 31, 2022.
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ICH-GCP
NSH research requires ICH-GCP re-certification every three years. If you complete ICH-GCP training through CITI or through Nova Scotia Health Research Education, your certificate will expire in three years.
Although three-year re-certification was surveyed to be the norm for most Institutions, some Sponsors do require two-year re-certification.
Formalized guidance on this will be released soon. In the meantime, if you/or the sponsor require proof of our three-year policy, please contact Andrea Dean ([email protected]).
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Clinical trials at Nova Scotia Health | |
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HR Update
The NSH Compensation & Benefits team issue a quarterly newsletter, which can be found within the NSH Newsletter. The Compensation & Benefits newsletter includes updates, contact information, and details on the benefits information sessions available through LMS. You can sign up for these sessions through our LMS platform and are facilitated virtually via Zoom. This is an opportunity to ask the Benefits team questions regarding your benefits package, forms, entitlements, or other questions you may have.
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Department of Pathology and Laboratory Services Update:
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Health Information Services Update:
Health Information Services (HIS) monitoring queues quick summary:
- All monitor queues are scheduled to be emptied. HIS have sent spreadsheets to Research Managers to identify their monitors and current queues. While there is no hard timeline to complete the information, it would be much appreciated if the form could be completed and returned as soon as possible.
- Queues will only contain encounters from the previous date of the monitoring visit.
- The monitor will be instructed to use the ‘complete’ button after viewing each encounter or at the end of the visit. The research coordinator will notify the Database Coordinator (DBC) at the end of the monitoring visit so the DBC can ensure the queue is empty.
- Queues will only be used once. A new queue will be assigned for each visit.
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The Internal Auditing program:
- Allows the Research Ethics Board (REB) to fulfil their commitment to the evaluation and subsequent assurance of human research protection and the ethical conduct of research within Nova Scotia Health.
- Verifies that research studies are conducted, and that data is generated, documented, and recorded in compliance with the study protocol, applicable regulations, standard operating procedures, and institutional policies.
- Utilizes audit findings to guide research excellence, quality improvement, system enhancements, and develop educational needs within NSH research.
- Provides real-life learning and improvement opportunities for research teams to establish best practice in clinical research.
Internal auditing allows for a ‘snapshot’ into the conduct of a study. There is no requirement to prepare for an audit. Any findings (non-conformities) are recorded in an audit report for the research team to review and provide CAPA (corrective action and preventative actions). Audits are meant as a learning opportunity for research teams and a way of working together to increase research excellence.
Did you know? Two of the most common non-conformities that are found in Nova Scotia Health audits are:
- ICH-GCP 2.10 “All clinical trial should be recorded, handled, and stored in a way that allows for accurate reporting, interpretation, and verification”
- ICH-GCP 4.8.6, TCPS 3.2(b), and REB Consent Preparation and Use document- Informed consent language should be non-technical, plain language, and at a Grade 8 reading level.
Telenursing:
Nova Scotia College of Nursing developed a document for telenursing. While not all research coordinators are nurses, the information in the document may help with developing best practice for everyone conducting virtual study visits: Telenursing.pdf (nscn.ca)
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Concomitant is a 17th century Latin word used as an adjective meaning accompanying or associated.
Concomitant medications are all those taken with the specified time frame before and during a clinical trial.
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