GENERAL CLINICAL RESEARCH CENTER/CLINICAL AND TRANSLATIONAL RESEARCH UNIT

This Web page is designed to provide Stanford GCRC/CTRU investigators
 and staff with general information, relevant forms, and direct 
access to other Web facilities.
  Contact: ctrustanford@stanford.edu

  Download or view the current GCRC/CTRU Protocol Application Form
- Detailed instructions for using the form

  Download or view the current 1070 Arastradero Road Clinic Protocol Application Form
- Guiding Principles for 1070 Arastradero Laboratory

Download or view the current Patient Reservation/Cancellation Form
- The form can be filled out in MS Word, then printed. The completed form can be Faxed or hand delivered to the CTRU (Fax #: 650.725.2582). Please Note: Make ONE reservation per page. If you have questions, please call CTRU nurse's station and speak with the Resource Nurse (3-6713).

Quick Jumps to information on this page:
GCRC/CTRU News
Support for Stanford Invesitgators
GCRC/CTRU Protocol Application Form Instructions
Patient Eligibility Information

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GCRC/CTRU News:

The May General Advisory Committee meeting is scheduled for Tuesday, May 22, 2012, at 11:00AM in the W1084 Conference Room of 900 Blake Wilbur.

The CTRU Application deadline for the May review meeting is May 1, 2012.

SUPPORT FOR STANFORD INVESTIGATORS
GCRC/CTRU investigators with active protocols may take advantage of our facilities and support systems.  The Stanford GCRC/CTRU provides all of the components essential to clinical research, including laboratory services, computer systems support, nutrition services, nursing support and biostatistics consulting.

GCRC/CTRU PROTOCOL APPLICATION FORM INSTRUCTIONS

Quick Jumps:
The Review Process
Cancer Protocols performed at the GCRC/CTRU
Request for CTRU services at the 1070 Arastradero Road research clinic
Download the Application
Required documents
Filling Out the Form
Following Approval
NIH Clinical Trials Description
NIH Study Types Descriptions
Cut & Paste to GCRC/CTRU Form

THE REVIEW PROCESS:

Protocol applications will be reviewed for CTRU resource utilization by CTRU staff (administration, nursing, laboratory, dietary). The chair of the CTRU Advisory Committee (CAC) will determine whether a scientific/medical review is required.

Stanford faculty initiated studies which have not had other peer review will be assigned by the CAC Chair for medical/scientific review. The CAC reviewer will transmit questions and comments to the P.I. of the proposed study, and will recommend one of the following actions to be voted on by the CAC: Approve, Approve contingent on response by P.I., Disapprove, or Defer pending major revisions or other considerations.

 The following protocols are exempt from medical scientific review by the CAC:

• Cancer protocols, reviewed by the Scientific Review Committee of the Cancer Center
• Studies which have been peer-reviewed via NIH or non-profit foundation grants
• Industry funded trials

The "Adult" CTRU Advisory Committee meets on the 4th Tuesday of each month.  A lead time of three (3) weeks is required for processing the complete application (i.e. the completed form along with the other required attached documents noted below) prior to the committee meeting. 

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 the CTRU Administrative Associate at 4-0921 or ctrustanford@stanford.edu for more details.

Request for CTRU services at the 1070 Arastradero Road research clinic:Spectrum (the Stanford Center for Clinical and Translational Education and Research) is providing support for research sample acquisition and processing at the 1070 Arastradero Road research clinic organized by the Department of Medicine. This support is through the Clinical and Translational Research Unit (CTRU) of Spectrum, and is administered by Ben Varasteh, the CTRU lab manager. Please contact Donna Adelman, the facility manager, for questions regarding the 1070 Arastradero clinic. Completed applications for CTRU support should be emailed to the CTRU Administrative Associate .

Prior to applying for use of the 1070 Arastradero Road laboratory services, please be sure to read the Guiding Principles.

Key contacts:
Donna Adelman, 1070 Research Facility Manager: donna@stanford.edu 724-3121

CTRU Administrative Associate: ctrustanford@stanford.edu, 724-0921

Ben Varasteh, Laboratory Manager: varasteh@stanford.edu, 723-7641

Dr. Branimir I. Sikic
Director, CTRU

Dr. Mark Genovese
Director, 1070 Arastradero

Note that you must use the current version of the form, as of February 2011.  Completed protocol applications should be submitted three weeks prior to the scheduled committee meeting:

Adult General Advisory Committee Meetings:

- February 22, 2011: Submit by February 1st
- March 22, 2011: Submit by March 1st
- April 26, 2011: Submit by April 5th
- May 24, 2011: Submit by May 3rd
- June 28, 2011: Submit by June 7th
- July 26, 2011: Submit by July 5th
- August 23, 2011: Submit by August 2nd
- September 27, 2011: Submit by September 6th
- October 25, 2011: Submit by October 4th
- November 22, 2011: Submit by November 1st
- December 13, 2011: Submit by December 1st (NOTE: meeting date pushed ahead to comply with mandatory University winter closure)

Meetings are scheduled for the fourth Tuesday of every month and the start time is 11:00am. The dates and times are subject to change.

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.

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APPLICATION FORM DOWLOAD:

Protocol Application Form (for ALL studies to be performed at CTRU, Cancer or otherwise):

> > > > > Application

Protocol Application Form for studies to be performed at 1070 Arastradero Road clinic:

> > > > > 1070 Application

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 ctrustanford@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.
   

FILLING 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).

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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 the CTRU Administrative Associate, ctrustanford@stanford.edu, phone 724-0921, at 1101 Welch Road, Building A3, Room A312, or if you need assistance with this process, or have technical questions about the application form. 

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: "Supported in part by the Clinical and Translational Science Award 1UL1 RR025744 for the Stanford Center for Clinical and Translational Education and Research (Spectrum) from the National Center for Research Resources, National Institutes of Health."

OTHER RELEVANT FORM INFORMATION

NIH CLINICAL TRIALS DESCRIPTION:
Clinical trials are prospective studies in human subjects designed to assess the safety, efficacy, and value of one or more interventions against a control. These new drugs, devices, treatments, preventive measures, or techniques are selected according to predetermined criteria of eligibility and observed for predefined evidence of effects or outcome.

Phase I clinical trial studies are performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, procedures, or techniques in healthy volunteer subjects or in patients. These tests are used to determine pharmacologic and pharmacokinetic properties, structure/activity relationships, safe dosage range, toxicity metabolism, absorption, elimination, preferred route of administration, and involve a small number of persons.

Phase II clinical trial studies are well controlled and closely monitored clinical studies to evaluate the safety, efficacy, or optimum dosage schedule of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are conducted with a relatively small number of patients, involving no more than several hundred subjects.

Phase III clinical trial studies are expanded studies performed after preliminary evidence suggesting effectiveness has been obtained. They are performed on patient groups, closely monitored by physicians, that are large enough, from several hundred to several thousand, to identify clinically significant responses.

Phase IV clinical trial studies are planned post-marketing clinical studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale.  These studies are often conducted to obtain additional data about the safety and efficacy of a product.

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NIH STUDY TYPES DISCRIPTIONS:
Type A - These studies are investigator-initiated and appropriate supportive documents need to be provided with the application if funding source is other than NIH. They consist of research inpatient days or outpatient visits utilized solely for research purposes.  All hospitalization costs associated with Category A research days or visits are the financial responsibility of the GCRC/CTRU grant or the investigator's research funds. Persons who are hospitalized for research purposes only, but whose care is partly supported by non-GCRC/CTRU funds, (e.g., other grants, industry) may also be classified as Category A. This category includes normal volunteers or control subjects and patients who may participate in research projects that include unproven forms of therapy or diagnostic techniques that may subsequently become standards of medical therapy or diagnosis.

Type D - The participating industry pays all charges for these patients directly; the GCRC/CTRU will assume no financial responsibility for them. Type D studies are defined as: "Patient days or outpatient visits utilized for an industry initiated study. All charges are paid directly by industry through the responsible investigator."

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.

CUT-AND-PASTE TO GCRC/CTRU FORM:
From other MSWord documents.
1.      Open both the form and the other document with the "Open" option under "File" on the top banner.
2.      Select the other document as the active document by selecting it under "Window" in the top banner.
3.      Highlight the section to be pasted into the form on the other document and copy it by selecting "Copy" under "Edit" on the top banner.
4.      Then make the form the active document by selecting it under "Window" in the top banner. 
5.      Place the cursor in the box that the copied information is to be pasted into and select "Paste" under "Edit" on the top banner.
6.      Save your work frequently! (select "Save" under "File")
Repeat steps 2 through 6 until all the information is pasted into the form.

PATIENT ELIGIBILITY INFORMATION
The following document is a sample Patient Eligibility Form. The usual procedure for using this form is to:
     1. Download the sample form as detailed below.
     2. Modify the details on the sample version to fit the criteria for your proposed GCRC/CTRU protocol.
     3. Submit your version of the patient eligibility form with your GCRC/CTRU protocol package (as detailed in the protocol form instructions).

Download an MSWord version of this form that works with both Mac and Windows versions of MSWord. After the form has been downloaded, save it to your hard drive.