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- Stanford Funding Information
Branimir Sikic, MD, Renee' Rittler, Michael Barany Siv Modler, Debbie Mattmann, Ben Varastah, Pat Schaaf, Susan Carter, 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
http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.html
* 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
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.
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).
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.
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.
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.