Research Oversight Committee: Annual Renewal Submission

An annual renewal occurs annually or unscheduled as appropriate. Studies must apply for annual renewal in order to continue the research at UW Medicine Valley Medical Center (annual submission), notify ROC of a significant adverse event (unscheduled submission), notify ROC of a significant protocol amendment (unscheduled submission) or to close the study with ROC (annual or unscheduled submission). Submissions are electronic and include the following:

  1. ROC annual renewal to conduct research form
  2. Current IRB approved renewal (status report)
  3. If the study has patient consents and/or HIPAA forms: send a copy of all signed VMC patient consents to the ROC Coordinator (since the last ROC submission)
    1. Consent submission is required on a quarterly basis*. The ROC Coordinator will submit copies of all consents to VMC HIM. 
    2. Send a copy of all signed VMC patient HIPAA forms to the ROC Coordinator (since the last ROC submission). Submission of signed HIPAA forms are required on a quarterly basis*. The ROC Coordinator will submit copies of all HIPAA’s to VMC HIM.
     
  4. If updated since the last ROC submission—
    1. Protocol
    2. Informed consent form(s), if applicable
    3. HIPAA form(s), if applicable
    4. New or updated study materials (Such as case report forms, telephone scripts, advertisement/flyers, educational tools, surveys, questionnaires, etc.)
    5. IRB Authorization Agreement 
     

* Please note, submission of VMC patient signed research informed consent forms and VMC patient signed HIPAA forms are required on a quarterly schedule. Visit Quarterly Submission of VMC signed research informed consent forms and research HIPAA authorization forms for instructions.

Forms

Use the Annual Renewal to Conduct Research form for all ROC annual renewals, notification of significant adverse event* (unscheduled submission), significant protocol amendment (unscheduled submission) and closure. 

* Significant adverse event is defined as ANY of the following: 

  1. Death of a patient treated by the investigator/study staff, 
  2. A serious adverse event of a patient treated by the investigator/study staff per sponsor definition 
  3. Halt of study per Data Safety Monitoring Board (or equivalent) due to adverse event(s)

The ROC Checklist Renewal study submission is a tool for investigators and/or study staff to utilize.

If the IRB Authorization Agreement Form updated since the last ROC Submission, please submit accordingly. 

Submit new study submission electronically to the ROC Coordinator at: Research@ValleyMed.org 

Full ROC study submission is due 2 weeks prior to the ROC meeting. Study review and ROC determination will be withheld until the ROC Coordinator verifies the submission is complete.   

Day of ROC meeting:
Study staff representative are not required to be present at the ROC meeting. Please contact the ROC Coordinator if you wish to attend the meeting.

Documentation of ROC determination:
The ROC coordinator will emails study staff the preliminary results. Formal letter will be sent to study staff via email within 1 week.   

If you have any questions regarding ROC or the review process, contact the ROC coordinator at Research@ValleyMed.org.