Dear Nova Scotia Health clinical trials community,

Thank you for tuning into the CTNewsletter. Our aim to for the newsletter to be helpful and informative. We would love to hear from you if you have comments or have suggestions for future editions.

Research Quality has grown over the last year to incorporate quality coordinators to help support quality assurance and regulatory compliance for all researchers. We would like to welcome Patrick O’Regan to the team as of February 27 2023!

We now have an email address to reach the entire team. The new email is ResearchQuality@nshealth.ca. We welcome you to reach out to us with any questions or concerns regarding research and clinical trials. We are here to support you!

There is no longer a requirement to complete the OHSW NSH entry forms. A worksheet has been created to ensure monitors can enter the facilities safely.|

The worksheet is not controlled by OHSW and is held by the research group in case there is a need for OHSW audit. The form is private and confidential and must be held in a secure location for 30 days, then destroyed as per institutional policy.

Helpful resource: Worksheet for monitors coming onsite.

Please refer to the COVID-19 Hub for updates on COVID-19 Guidelines for Contractors and Vendors. This is the current link to the online daily screening tool and protocol for safe entry that can be sent to monitors. Prior to sending the link, please ensure there is not more current information on the COVID-19 Hub.

If you have any questions, please contact ResearchQuality@nshealth.ca

N2 (Network of Networks):

N2 has released a Guidance for Health Canada Inspections. Happy to report the Quality program at NSH was part of the committee that developed this very helpful document.

NSH is a member of N2 and this membership includes all our researchers. To access N2 content, go to the N2 website; go to the right- hand corner that says “access N2 resources’

enter username: N2guest

Password: N2Canada@22!

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 June 1, 2023.

ICH-GCP

What is it?

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human participants. Compliance with GCP provides public assurance the rights, safety, and well-being of trial participants are protected, and clinical trial data are credible.

GCP was developed by the regulatory authorities of the EU, Japan, and the US, the regulatory authorities group named the Tripartite International Conference (ICH). The agreement called ICH-GCP became effective in 1999 and gained international recognition as a benchmark for best practice for clinical trials. Canada adopted ICH-GCP in January 2000.

There are 13 principles of GCP. Below are the ones that have the greatest relevance to the daily activities of research coordinators:



1. Freely given informed consent should be obtained from each participant prior to clinical trial participation.
2. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
3. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
4. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform their respective task(s).
5. A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB) approval, Independent Ethics Committee (IEC) approval or favorable opinion.
6. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, a qualified dentist.

You can find the complete list of the 13 principles of GCP in the Research Quality and Education section of the RID website.

Need to train or re-train on GCP?

       GCP training is required every three years.

1. Contact Andrea Dean to arrange a date and time, or
2.  Obtain GCP training through CITI

•  Log into N2 (instructions included in Regulations and Standards section)
• https://www.citiprogram.org/index.cfm?pageID=14

**please note, the Transportation of Dangerous Goods (TDG) training listed in CITI training does not meet Transport Canada regulations. Please contact Andrea Dean if you have questions or require TDG training**

Where you can find it: https://innovationhub.nshealth.ca/

The website is being populated daily to add meaningful and useful content to our research community. Please have a look to see the available content.

Examples of what you can find:

• Good Clinical practice
• Informed consent preparation guidelines

Please let us know if there are resources you would like to see added.

What is it?

Health Literacy is an individual’s ability and capacity to obtain, process, and understand basic health information.

• Health literacy basics are addressed in TCPS Chapter 3 excerpt: “a statement of the research purpose in plain language,…” , “a plain language description of all reasonably foreseeable risks and potential benefit,…”
• ICH-GCP 4.8.6: “the language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject’s legally acceptable representative and the impartial witness, where applicable”
• The REB looks for a maximum of a grade 8 readability of the consent form
• Health literacy promote the ethical conduct of research
• Respect for Person- the participant has the right to understand
• Beneficence- understanding can reduce psychological or physical harm
• Justice- equal access to research by providing information in a way that is understandable.                                                                                                                                                                                                                                                                                           How do we help achieve health literacy in research?
• De-mystify what research is and what happens during participation,
• Awareness campaigns
• Participant engagement.

Health Literacy is a two-way street

The person conducting the consent should be qualitied, trained, and familiar with the subject of the research and the content of the informed consent form and,

During the study:

• Explaining the steps of what will happen at each visit at the beginning of the visit
• Using grade 8 language to explain processes, procedures or summarizing information the participant has received (for example, after they have been seen by the study doctor)

Look for the guideline for informed consent form preparation on the website under Research Quality and Education.

• All clinical trials must be registered at ClinicalTrials.gov. Sponsors are responsible for keeping the information in the registry up to date.



• To register a clinical trial, please contact Courtney Heisler (courtney.heisler@nshealth.ca) or Pam Trenholm (pamela.trenholm@nshealth.ca). Please note Jenn Thurlow is no longer the contact person for registering at ClinicalTrials.gov.

Monitors should 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. 

One of the first drugs to come into common use is aspirin. It is still one of the most researched drugs in the world, with an estimated 700 to 1,000 clinical trials conducted each year. Aspirin’s use can be traced back to when the Sumerians and Egyptians used Willow as a medicine circa 3000 BC. Aspirin was termed such in 1899 by Bayer and has been researched heavily ever since.

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