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Becoming a TMG Investigator
If you are a primary care physician, practising in Canada, who would like to learn more about becoming a TMG investigator, please click here to access the Investigator Questionnaire. The completed form can be either emailed or printed out and faxed to TMG. We’ll get back to you as soon as possible to follow up with you personally. Please take a moment to review the following information to learn more about how TMG supports your clinical research.
Requirements of a Successful Clinical Investigator
- Respect for the implications of delivering quality research data
- Ability & willingness to communicate this approach to all research staff
- Qualified & talented research staff
- Attention to detail
- Standardization of research processes
- Large patient population (2,500 – 4,000+ patients)
- Ability to screen & recruit study subjects
- Active participation of investigator in study
- Careful screening & selection of studies appropriate to practice
- Adequate physical space to dedicate to monitoring visits, storage, etc.
- Adequate research amenities on site (centrifuge, spirometry, ECG, etc.)
- Adequate research amenities off/on site (endoscopy, x-ray, lung function, etc.)
- Investigator/staff commitment to ongoing training/professional development
TMG is seeking experienced and/or inexperienced Canadian investigators to join our family/general practice research network.
TMG Investigator Services
- 1. Marketing of Investigator Network
- 2. Screening Study Opportunities, Site Feasibility Completion & Submission
- 3. Training, Training Materials, Website Accessible Guidance & References
- 4. Provision of Investigator Site SOPs
- 5. Regulatory Document Package Preparation
- 6. Contract Review – Systematic Review/Negotiation Process
- 7. Source Document Worksheet Creation
- 8. Recruitment Support
- 9. Payment Administration: Tracking & Reconciliation, Timeliness, Advocacy
1. Marketing of Investigator Network
The most valuable of the marketing functions TMG undertakes are regular face-to-face meetings with pharmaceutical sponsors to promote the benefits of using TMG for the selection of their clinical investigators. TMG’s purpose is to make the identification of qualified, experienced investigators the most rapid (TIME), reliable (QUALITY), and cost-effective way (RESULTS) for companies to initiate and carry out their clinical projects.
The value of this is significant. For sponsors to identify qualified sites earlier, to initiate sites into their studies earlier, to meet their patient recruitment targets earlier, and to reduce the amount of time following up on data correction, means all of the resources these activities take are made available for the company’s use elsewhere in the drug development process.
TMG’s purpose is to provide a trustworthy source of experienced, well-managed investigators, to ensure sponsors get the best investigator(s) for their project, and to continually ensure all aspects of the sponsor-investigator relationship are optimized.
2. Screening Study Opportunities, Site Feasibility Completion & Submission
A site feasibility questionnaire provides a protocol synopsis followed by anywhere from one to 10 or more pages of site capability questions. Eighty percent of questions are the same for every study (site experience, IRB information, contact info. etc.). TMG completes the 80% for you and provides only the key study-specific questions for your review. As a result, TMG sites can review & complete more feasibilities in shorter time periods, improving your efficiency & allowing you to be a candidate for more studies for which you are interested and capable.
3. Training, Training Materials, Website Accessible Guidance & References
TMG’s success depends on the representation of well-trained, highly professional clinical investigators. Therefore we can only accept into our network physicians who are committed to ensuring they uphold the highest standards of Good Clinical Practice. For those investigators, TMG takes responsibility for ensuring they and their staff are trained in the latest regulatory requirements and the most effective tools to implement GCP at their sites. To complement our training seminars, TMG provides monthly interactive newsletters on GCP topics of interest, website access to study modules, past newsletters, regulatory references, staff training guidance and more.
4. Provision of Investigator Site SOPs
For Qualified Investigators, Health Canada Guide 0068 states that “the essential process should be described in a standard operating procedure (SOP) and evidence of satisfactory training of personnel involved in these processes should be documented.” TMG provides all TMG sites with SOPs for their clinical research conduct, updates these SOPs on a regular basis, and ensures that all sites are trained on their proper use.
In support of TMG Site SOPs, the TMG Quality Assurance program can perform QA audits (for compliance with the SOPs) and on-site training and/or mentoring visits to ensure that the reliability of data, and sponsor confidence in the TMG site is consistently superior to that of independent clinics.
5. Regulatory Document Package Preparation
Site initiation (study start-up) is a major cause of delays due to incomplete/incorrect completion of forms. For TMG sites, all document packages first come to TMG where they are pre-populated with your site information and presented to you in consistently well-organized packages with clear directions for completion & return. TMG sites receive one package containing all pertinent study documents ensuring sites have a clear understanding of all contractual and study obligations they are being asked to commit to. Upon return to TMG, document packages undergo an error-check, ensuring any mistakes are caught at TMG and not at the sponsor.
6. Contract Review – Systematic Review/Negotiation Process
The Clinical Trial/Study Agreement (CTA/CSA) is often glossed-over by investigators, who are often too busy to afford the time to read pages of legalese, are concerned about being perceived as unreasonable and not being selected for the study, or are trusting that the contract is written to sufficiently accommodate their interests. However as your legal representative in these agreements, TMG systematically goes through every word in the agreement to ensure your interests and obligations are fairly represented.
Why is this important? Consider this example: An investigator’s indemnification by the sponsor for claims based on study-related procedures is conditional on the investigator and staff following the protocol and adhering to the CTA. Therefore if the investigator does not understand their obligations throughout the entirety of the CTA, they are putting their indemnification from the sponsor at risk. The TMG review includes the insertion of template language to ensure the protection of the investigator throughout the CTA, whether in areas of privacy, subject injury, confidentiality, insurance obligations, indemnification, or elsewhere.
The study budget is reviewed and compared with TMG’s database of study procedures drawn from over 200 study budgets, to ensure reasonable fees are being provided for the procedures described. All components of the fees and payment terms are reviewed, and negotiated when appropriate.
7. Source Document Worksheet Creation
These worksheets assist study coordinators with the collection of all of the data required by the Case Report Form (CRFs) at each study visit. They are inserted in the patient chart and are used to document study information in an organized manner, that can be easily and accurately transferred to the CRFs. The completed worksheets then become part of the patient medical history. Therefore, TMG’s provision of these worksheets facilitates information management at our sites and helps to ensure the accuracy and completeness of data in the CRFs.
8. Recruitment Support
TMG manages any advertising for potential study subjects at all of the TMG sites. This means negotiating advertising budgets, creating ads (newspaper, radio, web), submitting ads for IRB & sponsor approval, paying for the ads & invoicing the sponsor, and following up with sites to determine the success rates of the strategies employed. When small ad budgets are provided, sites do not have to spend valuable time trying to get ads approved and placed in order to take advantage of the recruitment opportunity this presents.
9. Payment Administration: Tracking & Reconciliation, Timeliness, Advocacy
TMG tracks the enrolment progress weekly for TMG investigators, for each study that they participate in. TMG calculates the monies due, based on the procedures performed, and reconciles this data with payments received from sponsors to ensure accuracy and timeliness of all study payments. When payments are delayed, we are your advocates for timely follow up and keep all TMG sites informed of any expected delay beyond one week of the contract timeline. TMG can tell any TMG investigator at any time exactly how much is owed to them for each study and when it is due.