Protocol Application Information

An electronic version of the GCRC/CTRU Protocol Application Form is available for download from this Web page.  If you experience any problem downloading the documents call the GCRC/CTRU Administrative Associate, Michael Barany, at 4-0921 or send an e-mail to: gcrcstanford@stanford.edu

Note that you must use the current version of the form as updated versions are published as requirements change. Use of an old version of the form may delay processing.  Completed protocol applications should be submitted three weeks prior to the scheduled committee meeting:

Adult General Advisory Committee Meetings:

- January 27, 2009: Submit by January 6th
- February 24, 2009: Submit by February 3rd
- March 24, 2009: Submit by March 3rd
- April 28, 2009: Submit by April 7th
- May 26, 2009: Submit by May 5th
 - June 23, 2009: Submit by June 2nd
- July 28, 2009: Submit by July 7th
- August 25, 2009: Submit by August 4th
- September 22, 2009: Submit by September 1st
- October 27, 2009: Submit by October 6th
- November 24, 2009: Submit by November 3rd
- December 22, 2009: Submit by December 1st

Meetings are scheduled for the fourth Tuesday of every month in the GCRC/CTRU Conference Room (HH141) and the start time is 11:00am. The dates and times are subject to change.

Pediatric Advisory Committee Meetings:

- January 28, 2009: Submit by January 7th
- February 25, 2009: Submit by February 4th
- March 25, 2009: Submit by March 4th
- April 29, 2009: Submit by April 8th
- May 27, 2009: Submit by May 6th
- June 24, 2009: Submit by June 3rd
- July 29, 2009: Submit by July 8th
- August 26, 2009: Submit by August 5th
- September 30, 2009: Submit by September 9th
- October 28, 2009: Submit by October 7th
- November 25, 2009: Submit by November 4th
- December 23, 2009: Submit by December 2nd (NOTE: meeting date pushed ahead one week to comply with mandatory University winter closure)

Pediatric Advisory Board meetings are scheduled on the last Wednesday of every month, usually in the third floor conference room in Suite 305 of the 750 Welch Road building. The start time is 1:00pm. The dates and times are subject to change. Pediatric protocols are coordinated by Siv Modler, phone (650) 725-6575.


The difference between Adult and Pediatric GCRC/CTRU protocols: If you intend to use LPCH resources or Pediatric GCRC/CTRU Nurses only, then your protocol will be reviewed by the Pediatric Advisory Board. If your study will be generally held on the main GCRC/CTRU Unit in the hospital, then the General Advisory Committee will be reviewing the protocol. Please contact Michael at 4-0921 or for more details.

Protocols that will use BOTH Adult AND Pediatric GCRC/CTRU Resources will be reviewed by the appropriate committee depending on which unit will handle most of the study. The study will NOT need to be reviewed by both committees. For NIH reporting purposes, the study will be assigned an Adult and a Pediatric GCRC/CTRU number.

Cancer protocols to be performed at the GCRC/CTRU: Cancer Center Studies will use the same abbreviated CTRU Application Form as the other studies. You must also apply for review by the Cancer Clinical Trials Office's (CCTO)Scientific Review Committee (SRC). This committee performs many of the functions of the GCRC/CTRU review committee (scientific, statistical, and ethical reviews), so the protocol may be "fast-tracked" through GCRC/CTRU approval (pending SRC and IRB approval). Contact Michael at 4-0921 or gcrcstanford@stanford.edu for more details.

The CTRU Advisory Committee requires the PI or his/her responsible, knowledgeable representative to attend the committee review meeting.  The CTRU will contact both the PI and the contact person named in the application on the Monday prior to the Advisory Committee review meeting (Adult Advisory Committee usually scheduled for the 4th Tuesday of each month. Pediatric Advisory Committee usually scheduled for the last Wednesday of each month). If a member of the study team does not attend and questions remain unanswered, the protocol will be deferred to the following month.


Form download:

Application for ALL STUDIES:
Protocol Form:
  > > > > > 		Application  

Notes:

The GCRC/CTRU charges a $500 processing fee for type D studies.  For more information contact the GCRC/CTRU administrative director, Renee' Rittler, phone 3-7496. Contact Siv Modler for Pediatric protocols at 5-6575.

Also, concerning D studies:

  • Effective 9/1/07, the GCRC/CTRU will charge D studies $1315.26 for each inpatient day.
  • Effective 9/26/07, the GCRC/CTRU will charge D studies the nursing hourly rate of $105/hour for outpatient visits.

REQUIRED DOCUMENTS:
One copy of each of the following four (4) documents is required for review in addition to the completed CTRU application form (Electronic copies as e-mail attachments sent to gcrcstanford@stanford.edu).

  1. The original complete protocol.
  2. A copy of the current consent form.
  3. The IRB application as submitted to/approved by the Human Subjects committee.
  4. A copy of the Human Subjects Committee latest IRB approval notification letter.

FILLLING OUT THE FORM:
Please obtain a current copy of this form from the GCRC/CTRU each time you submit an application as new versions are published periodically.  Use of an old form may cause delays in the review process. Current copies of the GCRC/CTRU Application form are available for download.

Please do not respond to form questions with "refer to protocol."  With only a few exceptions, the responses should be essentially self-contained.  If a specific reference is made to an attachment as a part of the response, please give the attachment title along with the section and page number(s).  A reminder: Investigators must submit a revision to the IRB prior to initiating any modification to the original protocol.  This includes changes in treatment plan, patient eligibility requirements, or exclusion criteria.

Please respond to all components of each form item that are relevant to your proposed protocol. Use the tab key to move from response box to box. Use the arrow keys and return/enter key within a response box. Use the X-key to mark a check box (e.g. yes or no).

Be sure to follow the detailed instructions above for other required documents that make up a complete application.

For ALL Protocols - e-mail the completed form and required documents to Michael Barany, Administrative Associate, gcrcstanford@stanford.edu, phone 4-0921, at the Stanford University Hospital, room HG133.

If you need assistance with this process, or if you have technical questions about the form, please contact Michael at gcrcstanford@stanford.edu, phone 724-0921. 

FOLLOWING APPROVAL:
Please call the Nurse Manager at 723-6973 to arrange an in-service for the GCRC/CTRU staff prior to patient admission.  If there will be ancillary expenses, please contact Renee' Rittler, the Administrative Director, at 723-7496 prior to patient admission. Also, if lab services are needed call Ben Varasteh, the GCRC/CTRU Lab manager, at 3-5530. For kitchen services call Pat Schaaf, Senior Research Dietician, at 5-2558.

Publications resulting from research performed on the GCRC/CTRU should include the following statement: "The investigation was supported by Human Health Service grant M01-RR00070, General Clinical Research Centers, National Center for Research Resources, National Institutes of Health."