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Clinical Trials Office (CTO) Files

Document Library

Policies, Procedures & Guidelines

Any questions about these policies and procedures may be directed to the Scientific Review Committee.

Low Accrual Policy

ROS accrual policy updated December 2016

Data and Safety Monitoring Plan (DSMP)

updated April 2016

No Waiver Policy

 Updated September 2016

Cancer Center Priority Guidelines
Trial Activation Diagram
Lurie Cancer Center Research Oversight Diagram

 updated March 2015

Data Monitoring Committee (DMC) Standard Operating Procedures (SOPs)
DMC SOP 1: DMC Responsibilities
DMC SOP 2: Administrative Guidelines and Processes
DMC SOP 3: Publication Policies and Processes

 updated 07Oct2014

DMC SOP 4: Data Compliance Policies and Processes


Protocol & Project Submission Forms

Below are forms that may be required when submitting a cancer-relevant project to the Scientific Review Committee (SRC) for approval. Completed packets may be submitted to the SRC inbox at SRC.CCSG@northwestern.edu.

Please note that after May 1st, 2016 the February 2015 version of the NPSF will no longer be accepted. Please use the most recent version of the New Protocol Submission Form dated March 18, 2016.

 

Letter of Intent Template

must be submitted for all NU interventional investigator-initiated trials [IITs] prior to protocol submission; last updated Aug 2016.

New Protocol Submission Form (NPSF)

Updated 03.18.16



Disease Team Documents

Study Review Endorsement Form

 v 08Feb2017

Supplemental Clinical Trial Review Form


Scientific Review Committee (SRC) Documents

SRC FAQ
SRC Meeting Dates

updated 13Sep2016

Changes to the SRC Review Process, Oct 2016


 

Reviewer Forms

Thank you for agreeing to review a protocol for the Scientific Review Committee (SRC). Below are the study-specific and reviewer specific forms you are required to complete as part of your review. Please contact the SRC (SRC.CCSG@northwestern.edu) with questions.

Interventional Investigator-Initiated Primary/Secondary Reviewer Form

Updated 6/27/2016

Industry-Initiated Protocol Reviewer Form

Updated 6/27/2016.

Lab-Based Primary Reviewer Form

Updated 6/27/2016

Survey Report/Patient Reported Reviewer Form

Updated 6/27/2016

Interventional Investigator-Initiated Biostatistician Reviewer Form

updated June 27, 2016

Interventional Patient Rep Review Form

Updaed 6/27/2016

Interventional CRO Designee Reviewer Form

Updated 6/27/2016

Interventional Investigator-Initiated PCF Reviewer Form

June 6/27/2016

Interventional Investigator-Initiated Pharmacist Reviewer Form

Updated 6/27/2016

Investigator-Initiated QA Reviewer Form

Updated 6/27/2016



Data Monitoring Committee (DMC) Documents

Below are the most frequently used DMC forms. DMC SOPs detail all policies and procedures for any trial that adheres to the Lurie Cancer Center Data and Safety Monitoring Plan (DSMP). For further information and questions, please contact FSM CRO QAM.

Protocol Deviation Form
Internal Data Compliance Policy

PI is required to sign and acknowledge the policy for all trials that adhere to the Lurie Cancer Center Data and Safety Monitoring Plan [DSMP]

Participating Site Data Compliance Policy
DMC FAQ
DMC Semi-Annual Report Template

 v May2014

DMC Minimal/Moderate Semi-Annual Report Update

 v May 2014



Audit Committee (AC) Documents

NU Corrective Action Plan Template and Guidelines

 updated 07Oct2014

AC FAQ
Internal Audit Report Template

 v Oct2014



NU Investigator Initiated Trials (IIT)

Sites participating in NU IITs are responsible for reviewing and abiding by the policies and procedures in the SOPs below. Questions regarding these SOPs can be directed to Doreine Carson, Affiliate Program Manager

Participating Site Questionnaire (PSQ)
Obtaining NOTIS Access

for sites that will NOT use NU IRB as their IRB of Record

Participating Site Trial Activation Checklist
NU IIT Sub-contracts
Confidentiality Disclosure Agreement (CDA)
Disclosure of Financial Interest (DFI)
IIT Templates

Below are templates for different types of IITs. NU Investigators may use these templates when drafting or revising research protocols. For further assistance or information, please contact the CTO Medical Writers, Jennifer Kreutzer, Sabeeha Mukit, and Emily Meyers.

Interventional NU Protocol Template
Non-Interventional NU Protocol Template
Retrospective Chart Review Protocol Template
Summary of Changes Template for Investigator-Initiated Studies


ECOG

As an affiliate of NU, each institution is responsible for reviewing and abiding by the policies and procedures in the NU SOPs. Please contact Vera Jackson or our Affiliate Operations Department with any questions or concerns regarding ECOG SOPs.

Obtaining Access to NOTIS for ECOG Affiliates
ECOG Affiliate Site Contact List
ECOG-ACRIN Affiliate Regulatory Communications
CRO PRNC Tool

required only for ECOG affiliates that use the NU IRB when submitting a deviation that qualifies as PRNC

PRNC Chart for CG Trials at ECOG Affiliates that Use NU IRB
ECOG-ACRIN Affiliate Clinical Communications
ECOG-ACRIN Affiliate Audits


Misc

Lay Abstract Writing Instructions

How to access NOTIS and enter information about your protocol lay language

Cancer Center Phone List

Printable contact sheet with all a list Cancer Center staff including Study Coordinators and Data Managers, updated 08/17/15.

Useful CRO Acronyms
NU CRO SAE Summary Form

This form may be used for submitting all SAEs on NU Investigator-Initiated Trials (IITs).  Updated December 2016.  




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