You are the new CRA or study team member and have just received the go ahead for a protocol at a site in start up. Now what? Great question.
The following are the minimal documents you need to ensure you and your site have to begin work:
1. Final Protocol
2. Investigators brochure for the investigational drug.
3. Or, product monograph for an on-label study
4. Final informed consent
5. QIU- Qualified Investigator Undertaking form- Canadian sites
6. FDA-1572 form
7. REBA form – Research Ethics Board attestation form – if the ethics committee does not have the statement on their approval letter directly
8. Check for any patient facing documents- advertising, print, radio and Web based as well as social media based advertisement
9. Check for any paper or web/device based disease based rating scales for completion
10. Confirm if any central vendors need to approve site staff or qualify site staff for protocol specific activities, ie. Raters, radiology facilities, laboratories etc.
Now that all the documents are available, we will review each one (over a few posts) to ensure all that is needed for ethics submission and approval is done correctly.
In another post we will review all the documents & forms needed for sponsors to activate the site.
For the ethics committee submission, whether local ethics or a central ethics, the following process should be followed. Regardless of which type of committee is used, ensure you have reviewed the ethics committee process documents to confirm the submission conforms to their expectation. Remember, keep a copy of their process document to ensure subsequent processes we will discuss are followed and adhered to.
When submitting to ethics, you can follow these guidelines.
1. The letter of submission will need to contain very clear details of all documents submitted for review. The letter would need to include,
the protocol number and title, including the version date and or number letter.
The IB or PM for the study dug used will need to include the product name, and version date for the product and all safety documents from the data cut off as indicated in the IB.
Submit all safety letters, SUSARs, by MSN or other tracking indicators
All patient facing advertising , detailed by name and version number
All patient facing disease based rating scales, detailed by name and version number
For Canada, if a public website is to be used, ensure it conforms to the Health Canada regulations ( no sponsor, no drug name can be used, it can only provide general disease details for the indication ‘ an investigational or study drug’ is being studied and a central call in number can be added ) prior to posting and live and patient facing
Final sponsor approved ICF template, specific to the site, with version date or number
2. If working with a central IRB, ensure that any documents specific to the REB are known and completed. These may include, but not be limited to, an Investigator/Site form- 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.
More to come!