GENERAL CLINICAL RESEARCH CENTER/CLINICAL AND TRANSLATIONAL RESEARCH UNIT
Web page is designed to provide Stanford GCRC/CTRU investigators
and staff with general information, relevant forms, and direct
access to other Web facilities.
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).
Jumps to information on this page:
Support for Stanford Invesitgators
GCRC/CTRU Protocol Application Form Instructions
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.
PROTOCOL APPLICATION FORM INSTRUCTIONS
The Review Process
Protocols performed at the GCRC/CTRU
Request for CTRU services at the 1070 Arastradero Road research clinic
Filling Out the Form
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.
protocols to be performed at the GCRC/CTRU: Cancer Center Studies will use the same abbreviated
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 firstname.lastname@example.org
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.
CTRU Administrative Associate: email@example.com, 724-0921
Ben Varasteh, Laboratory Manager: firstname.lastname@example.org, 723-7641
Dr. Branimir I. Sikic
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
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
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.
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
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
- The original complete protocol.
- A copy of the current consent form.
- The IRB application as submitted to/approved by the Human Subjects committee.
- A copy of the Human Subjects Committee latest IRB approval notification letter.
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
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 the CTRU Administrative Associate, email@example.com,
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.
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.
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."
RELEVANT FORM INFORMATION
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.
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.
TO GCRC/CTRU FORM:
From other MSWord documents.
both the form and the other document with the "Open" option
under "File" on the top banner.
the other document as the active document by selecting it under "Window" in
the top banner.
the section to be pasted into the form on the other document and copy
it by selecting "Copy" under "Edit" on the top banner.
make the form the active document by selecting it under "Window" in
the top banner.
the cursor in the box that the copied information is to be pasted into
and select "Paste" under "Edit" on the top banner.
your work frequently! (select "Save" under "File")
Repeat steps 2 through 6 until all the information is pasted into the
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).
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.