/ Observational Registry & Expedited ReviewSite Status Report /
For assistance, please contact Quorum at 206-448-4082 or 1-877-IRB-9883.
PRINCIPAL INVESTIGATOR’S NAME / QUORUM INTERNAL USE ONLY
QR FILE #
Client Control #:
Institution Control #:
SPONSOR
APPROVAL DATE
EXPIRATION DATE
PROTOCOL NUMBER
This report is due by:
Complete and return this report by the due date. If your completed report is not received by the due date, Board review of your site may be delayed and Board approval may expire.
Section 1: Please choose ONEof the following options
PERIODIC SITE REVIEW / or / SITE CLOSURE
Please note that your study may be in various stages of completion and still requirereview. You may still require periodicsite review if you:
  • Have not yet initiated
  • Are active and currently enrolling
  • Are active but enrollment is closed and research activities are continuing
  • Have completed study activity but are waiting for sponsor close-out
/
  1. Has your site ever initiated study-related activities? (If no, skip to C.)
/ Yes No
  1. Has your site completed all study-related activities? (i.e., no currently enrolled participants and all interventions have ceased)
/ Yes No
  1. Please provide the date the sponsor or sponsor’s representative approved closure with the IRB. This date must be in the past.
/ MM/DD/YY
*For periodic site review, complete this entire form. *For site closure, complete question 1 and proceed to Section 3.

Section 2:

  1. My site is still recruiting participants for this study. Yes No N/A (Please check one)
  • If N/A please explain why:
  1. Below is a listed summary of the number of participants screened and consented at my site:
  • Number of participants who signed the consent form: (including screen failures)
  • Number of participants whoare currently active in the study at your site:
  • Number of participants who withdrew, discontinued, terminated or transferred sites:
  • Number of participants who completed the study at your site:

3. The most current version and date of the English main/core* Quorum approvedconsent form that has been received by my site is: Version Date OR N/A, if N/A please explain why:

*The version and date of the consent can be found in the footer of the consent, i.e., Version 1, dated 01/01/00. If you are unsure which consent form is the main/corestudy consent form, please call Quorum’sClient Support Team for assistance.

  1. Theconsent form cited above has been signed by participants at my site. Yes No N/A
  • If no or N/A, please explain why:
  1. My site is enrolling non-English speaking participants. Yes No N/A (Please check one)
  • If yes, all non-English speaking participants enrolled in sites under my supervision have received translated consent forms that have been approved by Quorum Review. Comments, concerns or exceptions as necessary:
  • If N/A please explain why:
  1. The Principal Investigator’s medical license expiration date is: OR N/A, the PI does not have a medical license.

Note: If the Principal Investigator is licensed in more than one state, please cite each expiration date and indicate the state next to the date that it applies to.

Section 3: As the Principal Investigator of the study listed aboveor the PI’s designee, I attest, to the best of my knowledge that the following statements are true. I will provide comments, concerns and documentationto any exceptions to the statements belowin the space provided and/or as attachments:

  • Anyrecruitment materials used by my site have been approved by Quorum Review.
  • This site has reported to Quorum allaudit findings of regulatory agencies, serious adverse events, major protocol deviations, unresolved participant complaints, claims for study related injuries, or other unanticipated problems. Any reportable events (according to Quorum Review Safety Information and Unanticipated Problems Guidelines) that have not yet been reported are enclosed.
  • I am not aware of any information or study findings that raise concerns about the study design or the accuracy of the consent form, or that would affect the assessment of risk or assessment of benefit by Quorum Review.
  • I am not aware of any changes in local laws or community attitudes that would affect how research is conducted at my site.
  • I have not experienced any adverse regulatory or licensing action, such as suspension or restriction of my medical license. Please note: If you have experienced any adverse action as listed above, please provide a letter of explanation and any associated documents.

Section 4: If you are currently receiving hard copy documents from Quorum, would you like to continue receiving them? Yes No

  • If no, documents will only be posted on the OnQ Portal.

As of 2014 Quorum’s price list includes an annual fee for this service. If the sponsor has not elected to pay for this, you will be billed for it. Please see your sponsor with questions.

SIGNATURE
By signing and/or submitting this form, I am confirming that the information is accurate and that I am the Principal Investigator (PI) or the PI’s designee authorized to submit on behalf of the PI and that the PI is aware of the information contained in this submission. The information provided above is true and accurate to the best of my knowledge.
PRINCIPAL INVESTIGATOR (OR DESIGNEE) PRINTED NAME: / TITLE (FOR DESIGNEE):
PRINCIPAL INVESTIGATOR (OR DESIGNEE) SIGNATURE** DATE

**A signature is not required if your site is submitting this form through the OnQ™ Portal.

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