Sites Participant Recruitment: FAQs
Do I need to use a submission cover sheet when submitting my recruitment or participant study material?
Quorum recommends submitting participant recruitment or participant study materials along with the Recruitment and Participant Study Materials Cover Page. Providing this document allows us to easily determine exactly what is being submitted, so we may properly route your items for processing. Failure to provide this document may result in a delay.
Participant Recruitment materials include:
- Printed materials: advertisements in newspapers, bulletin boards, posters, flyers, brochures, press releases, “Dear Patient” letters (for recruiting purposes), informational articles for recruitment purposes, newsletters, study synopses, etc.
- Audio/Video materials: radio scripts and recordings, public service announcement scripts and recordings, telephone screening scripts, television scripts and recordings, etc.
- Internet materials: Websites, Internet screening, banner ads, etc.
Participant study materials include:
- Diaries, instructions, and medication logs
- Other written instructions (for following study procedures, using study devices, following study dietary requirements, etc.)
- Participant information letters
- Appointment reminder cards, emergency unblinding cards
A Protocol Study Tool is a type of participant study material generated by the sponsor that is also described in the protocol as being given to participants as part of the study procedures and is generally used to collect study data. Protocol study tools that are included in the body of the protocol are reviewed as part of the protocol. Protocol study tools that are not part of the protocol or that are identified as appendices are reviewed as participant study material. Since the study tools are reviewed as participant study material, a “Quorum Approved” stamped copy of the protocol study tool is included with the approval document.
Yes, any gifts that will be given to participants should be submitted to Quorum for review.
Investigators may submit generic materials that are not associated with a specific study to Quorum Review for review and approval for generic use. If you think you have recruitment material that would qualify for the Generic Material Review option, contact Quorum and ask to speak to a Recruitment Specialist for more information about this option.
Some sponsors require sites to obtain sponsor/CRO approval for recruitment and participant study materials prior to use. In this case, Quorum requires written documentation from the sponsor or CRO indicating approval. This can be in the form or a letter or email and can be forwarded to Quorum from the site contact.
Materials that are “approved with modifications” by the Board must be resubmitted to Quorum with the requested modifications. The Board will verify these modifications prior to Quorum issuing an approval letter. If materials come back with changes in addition to modifications requested by the Board, Quorum considers the document to be a new submission and will result in additional charges as identified in the Quorum pricelist and could require sponsor approval, depending on the requirement of your sponsor.
Quorum recommends that scripts are submitted for review before production of the recording is started.
- After the script has received Board approval and the ad has been recorded, the final recording must be submitted for review prior to broadcast.
- After approval, radio scripts for live broadcast use must be read exactly as approved.
Please visit the FAQs for HIPAA under “Additional Services.”
Quorum offers translation services in over 100 languages and dialects for all study related documents, including recruitment and study materials. Please contact the Site Support Team if you would like more information regarding these services.
According to recruitment guidelines, internet listings where the system format limits the information provided to basic trial information, such as the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information do not require review.
If you are unsure if something requires review or not, you can submit a copy of the material to Quorum and ask to have a Recruitment Specialist analyze the listing to determine if your item requires review prior to use. If it is determined that the item does not require IRB review, our Recruitment Specialist will then send you a fax documenting the material does not require IRB review.
Yes, changes to previously approved recruitment or participant study materials should be submitted to Quorum Review IRB for approval prior to implementing the change.
Spelling corrections and changes to site specific contact information as indicated with space holders are allowed without additional approval from Quorum Review. If no space holders are present, the advertisement should not be modified.
Changes in size can be made provided that the changes are made to scale relative to the original approved material.
Recruitment and Participant Study Materials can be submitted to Quorum Review IRB using the OnQ Portal, fax or mail. If you have additional questions about an advertisement submission contact the Site Support Team for assistance.
What does “Replacement Material” mean on my recruitment and participant study material approval document?
Revised recruitment and participant study material intended to replace a previous version are identified as “Replacement Material” on the approval document. Approval for the new version will replace approval for the previous version.