FAQ Categories Participant Recruitment

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  1. What is the difference between compensation and reimbursement?

    Comments Off on What is the difference between compensation and reimbursement?

    “Compensation” refers to payment for participation in a research study.  “Reimbursement” includes reimbursement for parking and travel, the provision of gifts for participant retention purposes, or the provision of medical devices to be retained by the participant following the study, etc.”

    For more information see the Quorum Review IRB Handbook (requires an OnQ Portal account).

  2. We made modifications to my previously approved material, do I need to submit for review again?

    Comments Off on We made modifications to my previously approved material, do I need to submit for review again?

    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.

  3. Does a posting on ClinTrials.gov need review?

    Comments Off on Does a posting on ClinTrials.gov need review?

    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.

  4. I would like my materials translated, what should I do?

    Comments Off on I would like my materials translated, what should I do?

    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.

  5. What is Generic Material Review?

    Comments Off on What is Generic Material Review?

    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.

  6. How should I submit Recruitment or Participant Study Material to Quorum Review IRB?

    Comments Off on How should I submit Recruitment or Participant Study Material to Quorum Review IRB?

    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 Client Support Team for assistance.

  7. We made modifications to my previously approved material, do I need to submit for review again?

    Comments Off on We made modifications to my previously approved material, do I need to submit for review again?

    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.

  8. How does Quorum review radio and TV scripts?

    Comments Off on How does Quorum review radio and TV scripts?

    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.
  9. How do I get/communicate sponsor approval for my recruitment or participant study material?

    Comments Off on How do I get/communicate sponsor approval for my recruitment or participant study material?

    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.

  10. What does Quorum consider to be protocol study tools?

    Comments Off on What does Quorum consider to be 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 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.

  11. What does Quorum consider to be recruitment materials or participant study materials?

    Comments Off on What does Quorum consider to be recruitment materials or participant study materials?

    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
  12. Do I need to use a submission cover sheet when submitting my recruitment or participant study material?

    Comments Off on 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.