Presentation on theme: "CRC Protocol Documents Protocol Submissions Amendments Publications Study Closure."— Presentation transcript:
CRC Protocol Documents Protocol Submissions Amendments Publications Study Closure
Protocol Submissions The CRC Administrative Coordinator on White 1301 handles the CRC protocol submission information. Other Responsibilities of the Administrative Coordinator include: Handling the protocol/amendment submissions and Continuing Review applications Tracking online doctors orders Tending to the day-to-day administrative needs of the CRC
What is Needed to Submit a CRC Protocol Turbo protocol is the CRC Advisory Committee (CAC) - approved application form. Investigator or study staff must contact Faith Fortune, Administrative Coordinator, to obtain access to the Turbo Protocol Application Program. The completed Turbo file must be ed to (Please print 1 copy of Turbo Application for the CAC Submission). The Turbo application may be accessed from the Partners Start/Applications Menu.
What is Needed to Submit a CRC Protocol (continued) Submit 9 complete packets of each of the following items when submitting your protocol to the CRC Administration Office: Copy of the complete HRC application, as submitted to the HRC. If your study is HRC-approved, please include your HRC Review Questions/Comments with your packets. This includes detailed protocol, protocol summary and the most recent stamped, approved consent form (s). Protocols submitted under the new eIRB program can be sent electronically (all information above in one ) to be posted on a shared network drive for review rather than having 9 copies submitted.
What is Needed to Submit a CRC Protocol (continued) NIH Summary Sheet - The NIH Summary Sheet will need to be submitted with your application for (NIH-funded studies only). This will be needed as an alternative to the CRC Scientific Review of your study. Please this document as a PDF file to (If the project described in the NIH Summary sheet does not match the protocol, then a Scientific Review may be HRC approval letter. All approved amendments with accompanying documentation. the most recent complete set of Doctor’s Orders to even if they are in draft format.
What is Needed to Submit a CRC Protocol (continued) NIH Biosketches for PIs and Co- Investigators, along with complete Other Support pages to Budget for your study, as required by the NCRR guidelines. Forward one copy to Ed Andrews, Administrative Manager, via at
What is Needed to Submit a CRC Protocol (continued) A completed CRC new user form for all study staff. Send to Faith Fortune. You may find this on the CRC web site, Special fund number, if applicable, must be provided to Faith Fortune. HRC-required training must be completed by all members of the study team. Their names must be listed in the PHRC Required Training Database. This may be viewed at
How to Submit an Amendment to the CRC Timely reporting of amendments will ensure that research on the CRC is carried out as approved by the HRC and that we have all the necessary information reflected in the protocol on the CRC. The definitions below provide specific information we require for all amendments:
Amendment: Minor Changes Minor changes: Any change in a protocol that affects its conduct on the CRC must be discussed with the protocol nurse and/or protocol bionutritionist prior to submission of the amendment. For relatively minor changes, for example, the addition of another test tube during a routine blood draw, review of the amendment by the CRC Administrative staff is probably not indicated.
Amendment: Substantial Changes Substantial changes: More substantial changes in the conduct of a protocol (e.g. change in a medication that will be given, the frequency of administration of a study drug, or the addition of a new measurement on the CRC), the CRC must be informed immediately after approval of the amendment by the HRC. Please do not submit amendment material to the CRC prior to HRC approval. The investigator must submit the following for every approved amendment that reflects substantial changes:
What Information Needs to be Submitted for an Amendment Only one copy of the HRC-Approved Amendment Material is Required: HRC Amendment Form (must accompany amendment approval letter) [see attached form] Supporting documentation (i.e. revised protocol summary, detailed protocol, revised consent forms etc): The revised protocol must have an updated revision date and most recent amendment number reflected in the revised protocol summary and/or detailed protocol. HRC Approval Letter Revised protocol schema Revised Doctor’s Orders (if needed)
Amendment Form Sample
Amendment Changes that Affect CRC Budgeting Any changes that affect the CRC budgeting of a study must be approved by the Administrative Manager. Such changes would include any requests for additional ancillary funding or changed number of study visits or study subjects.
Amendment Changes to Study Staff Changes in staffing of a study that will affect conduct of the study on the CRC must be reported in order to validate that the staff member has received appropriate MGH training and CRC orientation. If there are new investigators added, an NIH biosketch and completed Other Support pages must be submitted.
Amendments & Turbo Revision Files For approved amendments in the above categories, we will also need a Turbo revision file. Please contact the CRC Administrative Coordinator for the most current version of the Turbo revision file for you to edit.
PUBLICATIONS Each publication, press release or other document that cites results from NIH grant-supported research must include an acknowledgement of NIH grant support and disclaimer such as "The project described was supported by Grant Number 1 UL1 RR , Harvard Clinical and Translational Science Center, from the National Center for Research Resources. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health". If your study utilized CRC resources (prior to 5/31/08), please use Grant Number M01-RR Please use both Grant Numbers if appropriate.
How to Close/Terminate a CRC Protocol Please notify the CRC Administrative Coordinator once your study enters data analysis and your sure no further patient visits will be scheduled. If your not sure further patients may be scheduled or re-entered into the protocol, its better to keep the study open during data analysis. Please notify the CRC Administrative Coordinator by if your study has been officially closed by the HRC Please notify the CRC Administrative Coordinator by if you do not wish to keep the study open on the CRC or do not plan on scheduling any more subject visits due to other circumstances.
CRC Administration Contact Information Edwin B. Andrews CRC Administrative Manager White 13 Room 1301A Phone:(617) Fax:(617) Faith M. Fortune CRC Administrative Coordinator White 13 Room 1301 Phone:(617) Fax:(617) To learn more about the CRC Program, please visit our website at: