Research Review

The Fox Chase Cancer Center Research Review Committee (RRC) generally meets three times per month to evaluate the scientific merit, general methodology, and statistical analysis of clinical research protocols prior to submission to the Institutional Review Board (IRB).  To submit a protocol for review, please provide an original and 4 copies (stapled) to the Research Review Coordinator in the Protocol Office no later than noon on the Thursday prior to the next scheduled meeting. Written comments are usually available within 48 hours of the meeting, which is held on Wednesdays at 7:45 AM.  Responses and/or amendments should be returned to the Protocol Office for re-review. 

All new protocols must be accompanied by a completed Request for New Protocol Review. An original Request for New Protocol Review along with 4 copies must be provided. This form requires a signature from the Department Chairman, Principal Investigator, and Fox Chase Co-Investigators. The form can be downloaded below.  Guidelines are also available for submission of research projects that utilize existing tissues and biospecimens.  Although grant applications can be submitted to outside agencies without prior review, funded clinical research projects cannot be initiated until review has been completed.  To facilitate the review process, investigators are encouraged to submit new clinical research proposals to RRC prior to funding.
Suggested Protocol Templates for investigator-initiated studies

 

Materials for Protocol Development, Review, HIPAA, and Investigator Registration

Documents

Request for New Protocol Review Form (MS-Word document-form):

newprotocol.doc

Request for New CIRB Protocol Review Form:

New_CIRB_protocol.docx

Guidlines for Investigator Registration with NCI and Groups (Acrobat PDF):

InvestReg.pdf

General Protocol Office Procedures for New Studies

Process_for_New_Protocol_Review.doc

FDA 1572 template for investigator registration:

FCCC1572.doc

Guidelines for studies using existing tissues and biospecimens (Acrobat PDF):

tissue_studies.pdf

Fox Chase Master Data and Safety Monitoring Plan (Acrobat PDF):

FCCCDSMPlan.pdf

Compassionate Use Studies, Standard Procedures:

compassionate_use

Guidelines for Preparation of Informed Consent Documents (Acrobat PDF):

InformedConsentPrep.pdf

Fox Chase IRB Informed Consent Template:

IRB forms page

Fox Chase IRB Future Use of Specimens Template:

IRB forms page

HIPAA Template, ALL STUDIES:

IRB forms page

Policy on Closing Poorly Accruing Trials

Poorly Accruing Trials.doc

Copies of all active protocols and IRB-approved consent forms are maintained in the Protocol Office, which is located on the second floor of the Clinical Research Unit (CRU). All protocols must include a valid data and safety monitoring plan, and investigators should review the  FCCC Data and Safety Monitoring Plan.  Additional information is available from the Protocol Office and Institutional Review Board (IRB) at Fox Chase Cancer Center. (Updated: 21-Feb-2006).

 

Position

Name

Phone

Room

E-Mail

Chariman

Hossein Borghaei, DO

215-214-4297

W368 Hossein.Borghaei@fccc.edu

Research Review Coordinator

Sharon Allen

728-1133

CRU 2nd Fl

Sharon.Allen@fccc.edu

Members

Aarti Bhatia, MD

728-3545

C307

Aarti.Bhatia@fccc.edu

Mark Buyyounouski, MD

214-3708

CRP-LL P0098

Mark.Buyyounouski@fccc.edu

Monica Davey

Joanne Dorgan, PhD

728-5893

P4170

Joanne.Dorgan@fccc.edu

Linda Fleisher, PhD

728-3690

510 TWP Line Road 2nd flr.

Linda.Fleisher@fccc.edu

Karen Gustafson, MD

728-7042

C427

Karen.Gustafson@fccc.edu

Marlane Guttmann, MD

728-3579

C121F

Marlane.Guttmann@fccc.edu

Michael Hall, MD

728-2861

Young 4033

Michael.Hall@fccc.edu

Jeanne Held-Warmkessell, MSN, RN, AOCN

728-0417 H4-139 Jean.Held-Warmkessel@fccc.edu

Angela Jain, MD

728-3545

C233

Angela.Jain@fccc.edu

Linda Kish, MS

Dwight D. Kloth, PharmD

728-3896 H4-128 dd_kloth@fccc.edu

Warren Kruger, MD

728-3030

P3029C

Warren.Kruger@fccc.edu

Joanne Ley, RN, CCRP

 Lainie Martin, MD

728-3023 C-307 Lainie.Martin@fccc.edu

Joshua Meyer, MD

728-2667

P-0125

Joshua.Meyer@fccc.edu

Michael Millenson, MD

214-4297

C307

Michael.Millenson@fccc.edu

Anthony Olszanski, MD

214-1676

C303

Anthony.Olszanski@fccc.edu

Elizabeth Plimack, MD

728-2987 C307 Elizabeth.Plimack@fccc.edu

Andrew Ridge, MD

728-3517 C-308 ja_ridge@fccc.edu

Stacy Su, MD

728-0417

Stacey.Su@fccc.edu

Kuang-Yi Wen, PhD

214-1645 510 TL, 3rdFl Kuang-Yi.Wen@fccc.edu