Sponsors/CROs 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
Protocol study tools include:
- Summaries of the study screening procedures
- Agreements to comply with study procedures or requirements
- Protocol-required questionnaires, surveys, and medical guidelines
What are the various ways that recruitment materials/participant study materials be submitted for review?
- For one investigator/site
- For all investigators in a study
- For a subset of investigators in a study
- For sponsor use at the national or regional level
- For generic use, not associated with a specific study
What is the difference between model, mini-model, and site recruitment and participant study materials?
Model and Mini Model Materials: A study sponsor may submit model participant recruitment and participant study materials on behalf of all or some of the investigators participating in a protocol. These materials may be approved without investigator-specific contact information, which can be added by the investigator after approval. Generally, model participant recruitment and participant study materials are reviewed by the Board and approved for use by all investigators in a study. However, a sponsor can identify a subset of investigators to use particular participant recruitment and/or participant study materials which will be approved as mini-model materials.
Participant Study Materials : Consistent with the review of participant recruitment materials, the Board requires the review of participant study materials to ensure that the materials are not unduly coercive or misleading and do not promise a certainty of cure beyond what is outlined in the consent and the protocol. “Quorum-approved” stamped copies of these materials are included with the approval document.
Protocol Study Tools: 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 to the protocol will be reviewed as participant study material. Since the study tools are reviewed and cited as participant study material, “Quorum approved” stamped copies of these materials are included with approval documents.
Why don’t our sites have stamped approved copies of the Diaries and Questionnaires (protocol study tools) submitted with the initial protocol?
Prior to March 1, 2010, protocol study tools were considered part of the protocol, and Quorum processed them as we would the protocol or any amendments to the protocol. We issued approval for the material on Notice of Approval documents for protocol study tools that were reviewed with the initial protocol submission and we issued approval on Amended Approval documents for protocol study tools that were approved during the course of a study. We did not distribute Quorum Review-approved stamped copies of protocol study tools to sites as we did not issue Quorum Review-approval stamped copies of the protocol to sites.
Protocol study tools submitted after March 1, 2010, will be processed as participant study materials and a “Quorum Approved” stamped copy of the protocol study tool will be provided with the approval document.
A participant retention program is a program that involves the provision of gifts or other incentives to enrolled participants to encourage their continued participation in a study. As an example, an investigator might offer $20 gift cards to participants who reach a particular study visit milestone. Or, a sponsor might provide inexpensive gifts (e.g., tote bags, pens, t-shirts, mugs, etc.) throughout a study. All participant retention materials must be submitted for review.
A study sponsor may submit recruitment materials to be used by the sponsor at the national or regional level. These materials can only be approved with sponsor contact information that is not specific to the investigator. National or regional recruitment and study materials will be reviewed by the Board and approved for use by the sponsor.
- Sponsor will be responsible for running and maintaining the campaign
- Sites will not receive approval for the materials from Quorum
- Materials must be submitted in final format
- No site-specific contact information or placeholders for site contact information (with the exception of a centrally managed site location listing) Examples: Recruitment materials containing 1-800 numbers for sponsor-run call centers or sponsor-run websites
- Generic advertisements such as brochures, print ads, web ads, or posters
- Generic telephone screening scripts
- Generic ads do not contain study-specific information
- The approval period for generic materials is one year. Materials will be annually re-reviewed automatically, unless correspondence is received to cancel the annual review process.
- Standard review fees apply for each annual review that occurs
- Materials must be submitted in final format
- Changes to approved generic material must be reviewed and approved prior to use
An investigator or sponsor/CRO/SMO may submit generic materials that are not associated with a specific study to Quorum Review for review and approval for generic use. The approval period for generic material is one year, with automatic annual review of the material. A courtesy notification of annual review will be sent prior to the annual review date. Annual review occurs until notification is received to cancel the annual review process.
Are there any differences in submission requirements when submitting generic recruitments materials versus study specific recruitment materials?
Generic Material Submissions require the Generic Material Submission Form.
When submitting a study to Quorum, sponsors have the option to require all site recruitment and participant study material to receive a written individual approval from the sponsor before being reviewed. If a sponsor chooses this option and a site submits materials without sponsor approval Quorum will contact the site to request sponsor approval before proceeding with the review of the materials.
What if I originally indicated that I wanted sponsor approval on site materials in the central Study Questionnaire but I now wish to change my preference (or vice versa)?
If you would like to change your preference from what was indicated on your Central Study Questionnaire, please contact your Study Manager.
Submitting recruitment or participant study material along with initial protocol or site submission materials reduces cost. Submitting materials this way reduces cost because there will be no charge for the review and preparation of all site approval documents.
If you are unable to submit recruitment and study materials along with the protocol and consent form, attempt to submit them either before sites have been reviewed or with as few sites approved as possible. (Sites that already have approvals will accrue additional charges when Quorum Review IRB prepares the approval documents for those sites; sites that don’t yet have approval will receive approval for those materials with their ICF and Notice of Approval documentation). An alternative would be to submit as a mini model ad if only a certain subset of investigators will require the material.
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 your Study Manager 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 send a copy of the material to your Study Manager 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. 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 your Study Manager for assistance.
Quorum asks that all Study-related correspondence is delivered through the designated contacts for the study. In the case of third party vendors and Advertising Agencies, it may be possible for these groups to submit recruitment materials but please provide written authorization from the primary study contact indicating that this person/company may submit materials on behalf of the sponsor.
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.
As of March 1, 2010, Sponsors will receive an approval letter for approved model recruitment and participant study material reviewed after study start up. The approval letter will contain a “Quorum Approved” stamped copy of approved material.
Model recruitment and participant study material approved during study start up will be cited on the Sponsor’s Letter of Approvability. A “Quorum Approved” stamped copy of the material will not be provided to the Sponsor at this time.