Effective February 19, 2007, all new MUH-CTRC protocols must be submitted using OSIRIS, the IRB electronic submission application.

In OSIRIS you must select the following choices is your protocol utilizes resources of the MUH-CTRC:

The MUH-CTRC Scientific Advisory Committee

• This committee reviews protocols for scientific merit, patient safety and utilization of resources.
• The committee meets once a month, on the third Friday of each month, in the Berkman Board Room, 7th floor, Room 727 of Montefiore Hospital.
• Submission of a new protocol must be two weeks prior to the meeting date. Submission deadline and meeting dates are available on the website.
• If you have not used the MUH-CTRC before, you or your designee may attend the meeting when your protocol is being reviewed. It is not mandatory, but attendance will offer the opportunity to clarify issues. Please contact Cathy Hensler at muhctrc@upmc.edu if you or your representative plans to attend.

The format of the protcol review is as follows:

• The assigned reviewers will present an evaluation or critique of your protocol.
• For a brief time, you will have the opportunity to respond or ask questions.
• Following this discussion, you will be asked to leave the meeting so that the committee can complete its review and discuss the protocol.
• The protocol review will result in one of the following:

1. Approval for implementation on the MUH-CTRC
2. Approval pending response to committee concerns
3. Revise and resubmit for full review by the committee
4. Disapproved

You will receive a written response from the SAC within three business days following the meeting. You will either be asked to respond to the concerns or take the committee suggestions into consideration and address them on your next modification or interaction with the IRB. If you are not asked to respond your letter will state you have SAC approval. If a response is requested you should respond to the committee concerns by the date requested on the letter. An approval letter will be sent from the SAC once the concerns have been addressed. A modification should be submitted in OSIRIS to address the concerns raised by the committee. The MUH-CTRC will receive electronic notification of the modification from the IRB and retrieve the documents from OSIRIS. When the modification has been given IRB approval you should contact Jacki Faircloth of Jill Huwe to schedule an implementation meeting on the MUH-CTRC You can contact them at 412-648-6691.

Each year, 2 months prior to the anniversary of the IRB approval date, a reminder will be sent to the investigator from the MUH-CTRC indicating impending expiration of the protocol. The renewal process is important in that we can evaluate the activity and costs of each protocol annually. The MUH-CTRC adjusts the approval date to match the IRB approval date. Therefore your protocol will always expire on the CTRC on the same date as the IRB. Please note that you should only submit your renewal to the MUH-CTRC after you receive IRB approval.

1. IRB approved protocol in the required format and dated consent form(s)
2. IRB letter of approval and IRB cover sheet
3. IRB Research Study Renewal Report
4. MUH-CTRC Renewal Submission Form, Cost Accounting Sheet(s) for screening, outpatient and inpatient visits. Reflecting visits remaining.
5. Funding Update and revised budgets as needed
6. Industry correspondence since prior submission
7. Progress report and summary of changes from prior year included on Submission Form
8. Publications that cite the use of MUH-CTRC resources stated as:
   “this publication was supported by funds received from the NIH/NCRR/GCRC Grant #5M01 RR00056” if the research was done prior to 10/1/06. For research that occured after 10/1/06 please cite grant number UL1 RR024153. If your protocol was conducted before and after 10/1/06 please cite both grant numbers in your publications.

Please remember to update your contact information for the PI, regulatory and research subject coordinators on the Renewal Submission Form. The submission forms are revised as needed, therefore you should always select a new form from the web site and not use the one from the previous year. Outdated submission forms will not be accepted and the review will not be performed until all documents have been recieved. If you are having difficulty completing the forms please contact our office for assistance.

Each year, 2 months prior to the anniversary of the IRB approval date, a reminder will be sent to the investigator from the MUH-CTRC indicating impending expiration of the protocol. The renewal process is important in that we can evaluate the activity and costs of each protocol annually. The MUH-CTRC adjusts the approval date to match the IRB approval date. Therefore your protocol will always expire on the CTRC on the same date as the IRB. Since you will be submitting thru OSIRIS you will upload the MUH-CTRC renewal form and any other relevant documents into OSIRIS. When you receive IRB approval you will need to notify the MUH-CTRC that your renewal has been approved by emailing us at muhctrc@upmc.edu. Please be sure to complete all the information requested on the MUH-CTRC Renewal Submission form, before uploading it to OSIRIS, including the following:

• Cost Accounting Sheet(s) for screening, outpatient and inpatient visits to indicate the visits remaining.
• Progress report and summary of changes from prior year. If you add subjects to increase enrollment or add ancillary testing please make sure to discuss this in the progress report.
• Publications that cite the use of MUH-CTRC resources should all be listed that occured during this renewal period. Publications should be cited as follows:
  “this publication was supported by funds received from the NIH/NCRR/GCRC Grant #5M01 RR00056” if the research was done prior to 10/1/06. For research that occured after 10/1/06 please cite grant number UL1 RR024153. If your protocol was conducted before and after 10/1/06 please cite both grant numbers in your publications.
• Funding Update - Submit revised budgets as needed and always include the grant number and/or the 32-digit University account that provides funding for the study

Additionally, you should submit any industry correspondence since the prior submission. The documents will be downloaded from OSIRIS by the MUH-CTRC administrative staff after receiving your notification that the study has recieved IRB approval. Following MUH-CTRC administrative and fiscal review, the renewal will be presented to the MUH-CTRC Scientific Advisory Committee for approval of continuation. The investigator will receive notification once the protcol is approved. If the protocol is not submitted for renewal by the IRB expiration date, it will be considered as “inactive.” If not acted upon, in a timely manner, you will be contacted and the protocol will be terminated for use on the MUH-CTRC.

Please remember to update your contact information for the PI, regulatory and research subject coordinators on the Renewal Submission Form. The submission forms are revised as needed, therefore you should always select a new form from the web site and not use the one from the previous year. Outdated submission forms will not be accepted and the review will not be performed until all documents have been recieved. If you are having difficulty completing the forms please contact our office for assistance.

The University of Pittsburgh Cancer Center(UPCI) grant requires that all UPCI investigators submit their protocols to the UPCI-Protocol Review Committee (PRC) for scientific review. For this reason the protocols are not submitted to the MUH-CTRC Scientific Advisory Committee.

If you are a principal investigator(PI) or coordinator submitting a protocol that will utilize the resources of either the Hillman CTRC, the Montefiore CTRC, or both, you must follow the process established by the UPCI Regulatory office. Since all UPCI protocols are submitted in OSIRIS the CTRC administration receives an email notification from the IRB when our resources are requested. This not only applies to the MUH-CTRC and Hillman-CTRC but also to all the CTRC facilities. The protocol goes thru the normal review at the UPCI-PRC committee. At the time the protocol is assigned to reviewers the nursing administration at the MUH-CTRC and Hillman CTRC are notified by the UPCI regulatory staff if the CTRC resources are being requested. The nursing staff reviews the protocol at that time to see if it is appropriate for utilizing the CTRC resources, and their comments are incorporated into the UPCI-PRC review sent to the investigator.

After the protocol has scientific approval by the UPCI-PRC, the protocol then is opened for ancillary review in OSIRIS. At this time the UPMC Clinical Trials Fiscal Review begins. The MUH-CTRC administration is notified by UPMC Fiscal and a concurrent fiscal review is performed. At this time the final budget and contract need to be provided to the UPMC Fiscal team by the coordinator or the UPCI Fiscal Department. A CTRC review of the protocol will not be completed without these documents to review. In addition, the CTRC New Protocol Submission form must accurately reflect all visits, ancillary tests, and the funding to support each test requested. This applies to all studies which include, but are not limited to, industry sponsored studies, investigator-initiated industry studies, foundation supported, departmental seed funding, and grant sponsored, etc. If there are questions that arise during the MUH-CTRC fiscal review you will be contacted. If approved, an email will be sent to the PI and coordinator from the MUH-CTRC administration. Once the MUH-CTRC fiscal review is completed, the PI/Coordinator may schedule an implementation meeting after the protocol is IRB approved. The IRB approved protocols are presented for final approval at the next MUH-CTRC Scientific Advisory (SAC) committee meeting, however, we will not hold up the study from being implemented if a subject is ready to be enrolled prior to the next SAC meeting.

Modifications should be submitted in OSIRIS and the protocol must be renewed annually on the CTRC. If you have questions during the submission process related to the MUH-CTRC or Hillman-CTRC please contact our offices.

• Revised Protocol
• Revised Consent(s)
• IRB Cover Sheet
• IRB Modification Report
• IRB approval letter
• Any relevant correspondense including the IRB comments/concerns.

We are required to have the most current version of the protocol and consent on file in our office. Also, it is important that you update your contact information with us at this time. If the coordinator has changed please notify us with the updated information. The protocol modifications will be reviewed by the administrative and nursing staff. The protocol may be reviewed by our Scientific Advisory Committee if needed. You will receive an approval letter for the Modifications from the MUH-CTRC for your files.

Modifications Submitted via OSIRIS

If your protocol is in OSIRIS and you are submitting your modification to the IRB via OSIRIS you will need to notify the MUH-CTRC via email at MUHCTRC@upmc.edu after you receive IRB approval. Once notification is received, the administrative and nursing staff at the MUH-CTRC will review your modifications in OSIRIS. You will be contacted if we have any questions or concerns. You will receive an approval letter for the Modifications from the MUH-CTRC for your files. The MUH-CTRC will download all the documents from OSIRIS for our protocol file.