2. If working with a central IRB, ensure that any documents specific to the REB are known and completed. These may include an Investigator/Siteform- providing site and PI details, a checklist for patients to sign, a place for initials on the footer of each page are a few examples.
3. The same applies for the submission letter to either central or local ethics board. The more detailed, comprehensive and complete the submission letter is, it will reduce the need for revisions and reduce start up delays.
2. Investigators brochure. These are typically used when the molecule in study has not been approved by the local health authority in the specific country. It contains all the essential animal data and any updates to date current available clinical trial data with adverse event profiles beginning to be generated. If the molecule has been in study in humans for a period of time, there may be clinical data included with a ‘cut-off’ date. That date corresponds to all clinical data is being used up to and including that date and contained in the brochure. Investigators are encouraged to review these data to become familiar with the side effect profile of the study drug and othe key information aboutvthe molecule. Should the ethics committee have some questions, the PI may address them in the context of his experience in the therapeutic area in conjunction with the product knowledge. It is always A good idea to have the sponsors scientific team assist where possible as well.
In supplement to the IB, based on when the study begins, it may be necessary to provide the team a listing and disk containing the safety reports generated since the cut-off date in the IB. At the time of submission to the ethics committee, it is important to ensure the site has all the necessary information available at the time of start up
3. Product monograph. This document is used when the product used as study drug is approved on the market in the specific country, and it is studied per the local indication. The safety reference document at the sponsor would be called the ‘Core data sheet’. It contains the specific product details, adverse event profile and the indication for use, and administration details.
4. Final informed consent
Sponsors will routinely provide a template consent form. It is highly recommended that it be reviewed against the protocol to ensure it is accurate, reflecting all expected visits and assessments study subjects need to complete. We are all human, and mistakes happen. Ensure the ICF contains all the necessary elements required based on ICH-GCP guidelines. On another post I will discuss the required ICF elements. The ICF will need to be customized to the site specifics. If a local, IRB site, the study coordination may do this. If a central IRB site, the central IRB may customize the consent by site.
Submit the ICF as approved by the sponsor. This is an important element. If the sponsor has reviewed the ICF, they will help to limit any potential delays for missing elements and additional back and forth after IRB approval. Ensure the ICF version date / version identifier is added to the submission letter. When any changes are made, be sure to update the footer version with each change-this helps with version control.
5. QIU- Qualified Investigator Undertaking form- Canadian sites
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/form/qual_invest_under_form-eng.php
Please review this statement to ensur you and the PI understand the responsibilities.
QIU Statement: In respect of the identified clinical trial, I certify, as the qualified investigator for this site that:
• I am a physician or dentist and a member in good standing of a professional medical or dental association as defined in Part C Division 5 of the Food and Drug Regulations;
• I will supervise the medical care and medical decisions respecting this clinical trial at this site;
• I will conduct this clinical trial in accordance with Good Clinical Practices; and
• I will immediately on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the Research Ethics Board for this site of the discontinuance, provide them with the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons.
6. FDA-1572 form
I would encourage you to read the back to really understand, and reacquaint yourselves with the “commitments” being signed and agreed to. I think typically we do these so often with sites, we have actually lost touch with what it means to sign that document.
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf
Further specifics on each document will be posted.
Please let me know your thoughts on this post. I look forward to hearing from you!