LINKS

- GCRC Stanford Main Web Site

- Stanford University

- Stanford School of Medicine

- Stanford Hospital & Clinics

- Packard Children's Hospital

- NIH Web Site

- NCRR Web Site

- Stanford Funding Information


GCRC STAFF

Branimir Sikic, MD,
brandy@stanford.edu
Program Director   5-6427

Renee' Rittler,
rittler@stanford.edu
Admin Director  3-7496

Michael Barany
gcrcstanford@stanford.edu
Admin Assoc. 4-0921

Siv Modler, 
siv@stanford.edu
Peds Coord.  5-6575

Debbie Mattmann, 
dmattmann@stanfordmed.org
Nurse Mgr. 3-6973

Ben Varastah, 
varasteh@stanford.edu
Lab Mgr.  3-5530

Pat Schaaf, 
pschaaf@stanford.edu
Sr. Research Dietitian  5-2558

Susan Carter,
secarter@stanford.edu
Research Dietitian  5-2589


GCRC Unit Desk (Nurses), 3-6713

GENERAL CLINICAL RESEARCH CENTER

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

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

  Axis Codes or click here
  View current Patient Safety information at: 
    http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.html 
 GCRC Adult Protocol Review Committee Web page*
  GCRC Peds Protocol Review Committee Web page*
 GCRC Investigator's Web page

 GCRC Safety Committee (OMD) Web page

  Patient Eligibility Form download

  Demographic information gender/minorities

* A GCRC password is required for access to this resource - contact the GCRC for detail: gcrcstanford.edu.

Quick Jumps to information on this page:
GCRC News
Support for Stanford Invesitgators

GCRC Protocol Application Form Instructions
Patient Eligibility Information
Protocol Review Committee Web Pages
Scientific Axis Codes

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GCRC News:

The May 2008 General Advisory Committee meeting is scheduled for Tuesday, May 27th at 11:00AM in the GCRC Conference Room (HH141).

The May 2008 Pediatric Advisory Board meeting has been CANCELLED. The next meeting is scheduled for Wednesday, June 25th at 1:00PM in the Suite 305 Conference Room of 750 Welch Road (unless otherwise notified).


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


GCRC PROTOCOL APPLICATION FORM INSTRUCTIONS

Quick Jumps:
The Review Process
The Difference Between Adult and Pediatric Protocol Reviews

Cancer Protocols performed at the GCRC
Download the Application
Required documents
Filling Out the Form
Following Approval
NIH Clinical Trials Description
NIH Study Types Descriptions
Cut & Paste to GCRC Form


THE REVIEW PROCESS:
The "Adult" GCRC 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. 

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

Protocols that will use BOTH Adult AND Pediatric GCRC 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 number.

Cancer protocols to be performed at the GCRC: There is an abbreviated GCRC Application Form to be used for ALL studies dealing with cancer. 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 review committee (scientific, statistical, and ethical reviews), so the protocol may be "fast-tracked" through GCRC approval (pending SRC and IRB approval). Contact Michael at 4-0921 or gcrcstanford@stanford.edu for more details.

Note that you must use the current version of the form, as of March 2008, version 11g, as it contains patient safety information that the NCRR/NIH requires we keep on file and then include in our annual report to them.  Older versions of the form may not have the patient safety information included.  Completed protocol applications should be submitted three weeks prior to the scheduled committee meeting:

Adult General Advisory Committee Meetings:

- March 25, 2008: Submit by March 4th
- April 22, 2008: Submit by April 1st

- May 27, 2008: Submit by May 6th
- June 24, 2008:
Submit by June 3rd
- July 22, 2008: Submit by July 1st
- August 26, 2008:
Submit by August 5th
- September 23, 2008: Submit by September 2nd
- October 28, 2008:
Submit by October 7th
- November 25, 2008: Submit by November 4th
- December 16, 2008: Submit by December 2nd (NOTE: meeting date pushed ahead one week to comply with mandatory University winter closure)


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

Pediatric Advisory Committee Meetings:


- March 26, 2008: Submit by March 5th
- April 30, 2008: Submit by April 9th

- May 28, 2008: Submit by May 7th
- June 25, 2008:
Submit by June 4th
- July 30, 2008: Submit by July 2nd
- August 27, 2008:
Submit by August 6th
- September 24, 2008: Submit by September 3rd
- October 29, 2008:
Submit by October 8th
- November 26, 2008: Submit by November 5th
- December 17, 2008: Submit by December 3rd (NOTE: meeting date pushed ahead one week to comply with mandatory University winter closure)


The Pediatric Advisory Committee meetings are held 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 investigator or his/her representative MUST be present at the GCRC Advisory Committee meetings in order to respond to questions from the committee.  Please call 724-0921 for details.

Prior to the scheduled committee meeting, a committee member will review the submitted form and attached documents by a medical, statistical, ethics, and patient safety reviewer. Investigators will sometimes be contacted by the committee reviewer if any questions arise.

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FORM DOWLOAD:
This form is designed to be used with Windows versions of Microsoft Word

PC version

Protocol Form:
(click on "Form11h") > > > > > Form11h

This form is designed to be used with Mac Office 98 /2001/ X versions of Microsoft Word.

Macintosh version

Protocol Form:

(click on "Form11h") > > > > > Form11h

Please use the form below if your study deals with CANCER in any form. This is an abbreviated GCRC application to be use ONLY for cancer studies.

Cancer Studies Application

Protocol Form:

(click on "Form2d") > > > > > Form2d


REQUIRED DOCUMENTS:
One copy of each of the following documents are required for review as attachments to a completed GCRC application form (Electronic copies as e-mail attachments sent to gcrcstanford@stanford.edu or on a PC or Mac floppy or Zip disk with the application are mandatory, but paper copies are accepted in certain cases, check with Michael.):

a.)    The original complete protocol.
b.)    The Human Subjects Committee approval notification.
c.)    The IRB application and the approved IRB consent form.
d.)    A patient eligibility checklist form as described in item 4 of this application. (An example is provided for your use
Note, you should modify the downloaded form to fit your protocol criteria.)
e.)    All agreements with drug companies or other source, if any.
f.)      The NIH requires that we justify patient type A vs. type D status studies (see descriptions below). Therefore, if you are conducting a drug study, please provide documentation that you initiated the study (e.g., a letter clearly indicating that you approached the drug company for permission to use the drug - the drug company did not approach you).

FILLING OUT THE FORM:
Please obtain a current copy of this form from the GCRC 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 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 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 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 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 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."


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 grant or the investigator's research funds. Persons who are hospitalized for research purposes only, but whose care is partly supported by non-GCRC 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 B - This category pertains to patients who require hospitalization or outpatient studies for diagnostic or treatment according to established standards of care.  Although these patients also participate in GCRC-based research studies, the cost of established medical care, non-research care, for B patients, is not charged to the grant. The patient or third-party carrier is responsible for these costs. The cost of those ancillary services performed solely for research on B patients and not related to their routine medical care should be charged to the grant and not appear on the patient hospital bill which is submitted to either the patient or the insurance carrier.

Type D - The participating industry pays all charges for these patients directly; the GCRC 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 charges a $500 processing fee for type D studies.  For more information contact the GCRC 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 will charge D studies $1315.26 for each inpatient day.
  • Effective 9/26/07, the GCRC will charge D studies the nursing hourly rate of $105/hour for outpatient visits.

CUT-AND-PASTE TO GCRC 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 protocol.
     3. Submit your version of the patient eligibility form with your GCRC 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.


PROTOCOL REVIEW COMMITTEE WEB PAGES

The Stanford GCRC has two protocol review committees, the adult review committee and the pediatrics review committee.

The pediatrics review committee meets on the last Wednesday of every month, when new protocols have been proposed that meet the criteria for pediatrics protocols.  Completed applications are to be delivered via e-mail to the GCRC administrative associate three weeks prior to the committee meeting. Contact Michael Barany, phone 4-0921, for details and scheduled meeting dates.  A GCRC password is required for access to the pediatric protocol review committee Web site.

As noted above, the adult review committee meetings are scheduled for the fourth Tuesday of each month, with completed applications delivered to the GCRC administrative associate three weeks prior to the committee meeting.  A GCRC password is required for access to the adult protocol review committee Web site.


 

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Scientific Axis Codes (Area I)

  Code           Description
1a            Animals (Whole):  Vertebrates, Mammal
1b            Animals (Whole):  Vertebrates, Non-Mammal
1c            Animals (Whole):  Invertebrates
1d            Animals (Cell-Org):  Vertebrates, Mammal
1e            Animals (Cell-Org):  Vertebrates, Non-Mammal
1f            Animals (Cell-Org):  Invertebrates
2              Biological/Chemical Compounds
3              Biomaterials
4              Human, Cells Only
5a            Human, Adult, Female
5b            Human, Adult, Male
5c            Human, Infant/Child, Female
5d            Human, Infant/Child, Male
6                Membrane/Tissue/Isolated Organ
7a                Microorganisms ? Bacteria
7b                Microorganisms ? Virus
7c                Microorganisms ? Parasites
7d                Microorganisms ? Other
8                Plants/Fungi
9                Technology/Technique Development
11            Facility Construction/Improvement           
12a          Clinical Trials ? Multicenter
12b          Clinical Trials ? Single Center
12c          Clinical Trials ? Phase I
12d          Clinical Trials ? Phase I&II
12e          Clinical Trials ? Phase II
12f           Clinical Trials ? Phase II&III
12g          Clinical Trials ? Phase III
12h          Clinical Trials ? Phase III&IV
12i           Clinical Trials ? Phase IV
13                Cardiovascular System
14                Connective Tissue
15                Endocrine System
16a                Gastrointestinal System ? Esophagus
16b                 Gastrointestinal System ? Gallbladder
16c                 Gastrointestinal System ? Intestine
16d                 Gastrointestinal System ? Liver
16e                 Gastrointestinal System ? Pancreas
16f                 Gastrointestinal System ? Stomach
17                  Hematological System
18                  Integumentary/Skin System
19                  Lymphatic and Recticulo-Endothelial System
20                  Muscular System
21            Nervous System
22                  Oral/Dental
23                  Reproductive System
24                  Respiratory System
25a          Sensory System ? Ear
25b          Sensory System ? Eye
25c          Sensory System ? Taste/Smell
25d          Sensory System ? Touch
26            Skeletal System
27            Urinary System
28            Other (SPECIFY)

Scientific Axis Codes (Area II)
  Code           Description

30            Aging
31            AIDS, SAIDS, HIV, SIV
32                Anesthesiology
33                Alternative Medicine
34                Anthropology/Ethnography
35            Arthritis               
36                Behavior/Psychology/Social Sci
38                Bioethics             
39                Biotechnology (rDNA, cDNA, Hybridoma)
40                Communication/Speech
42                Computer Science
44                Congenital Defects or Malformations
45                Deafness/Hearing
46                Degenerative Disorders
48            Device, Prostheses, Intra/Extracorporeal
49            Diabetes               
50a                Drug/Therapeutic Agent Studies: Toxic
50b                Drug/Therapeutic Agent Studies: Other
50c                Drug/Therapeutic Agent Studies: Orphan Drugs
51            Education
52                Engineering/Bioengineering
54a                Environmental Sciences ? Toxic Substances
54b                Environmental Sciences ? Other
55            Gene Therapy
56                 Epidemiology
57            Fitness, Physical
58            Genetics, Including Metabolic Errors
59            Genome
60            Growth and Development
62            Health Care Applications
63a          Imaging: CT
63b          Imaging: Laser
63c          Imaging: MRI, MRS
63d          Imaging: NMR
63e          Imaging: PET
63f           Imaging: Spect
63g          Imaging: Radiography
63h          Imaging: Ultrasound
63i           Imaging: Microscopy
63j           Imaging: Near Infrared
64            Immunology and Allergy
65            Infant Morality
66                Infectious Diseases
67            Nursing Care Research
68                Information Science
69                International Health
70                Instrument Development
71                Maternal and Child Health
72            Mental Disorders/Psychiatry
73            Men?s Health
74a                 Metabolism: Carbohydrate
74b                 Metabolism: Electrolyte/Mineral
74c                 Metabolism: Enzymes
74d                 Metabolism: Gases
74e                 Metabolism: Hormone
74f                 Metabolism: Lipid
74g                 Metabolism: Nucleic Acid
74h                 Metabolism:  Protein & Amino Acid
75a          Minority Health: Asian/Pacific Islanders
75b          Minority Health: Blacks
75c          Minority Health: Hispanics
75d          Minority Health: Native Americans
75e          Minority Health: Other
76a                 Neoplasms/Oncology/Cancer ? Benign
76b                 Neoplasms/Oncology/Cancer ? Malignant
77            Model Development
78            Nutrition
79            Pain
80                Radiology/Radiation/Nuclear Medicine
81            Rare Disease
82                Rehabilitation
83            Sexually Transmitted Disease
84                Statistics/Mathematics
85            Sleep Research
86            Surgery
87            Substance Abuse
88                Transplantation
89            Structural Biology
90                Trauma/Burns/Injury
91            Vaccine
92            Other (SPECIFY)
93            Women?s Health Research
94            Prevention
End of AXIS Codes

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300 Pasteur Drive - H1
Stanford, CA 94305-5251
GCRC Nursing Center: (650) 723-6713
Facsimile: (650) 725-6698
Contact the GCRC at: gcrcstanford@stanford.edu

Last reviewed: 03/23/2005
Copyright 2002 - 2005 Stanford University, all rights reserved.