CCR Standard Operating Procedures

This page contains links to the following categories of SOPs:

Administrative - Clinical Research (ADCR)

SOP #

SOP Title

 Version # Version Date

ADCR-1

SOP Review and Approval Process - Developing and Maintaining SOPs

1.0March 2015

ADCR-2

CCR Participant Registration & Status Updates

2.0April 2016

ADCR-3

How to Change a Protocol Number in CRIS

1.2August 2011 
ADCR-4Admission, Travel, and Voucher Process  

ADCR-5

Reimbursing Healthy Volunteers

  

ADCR-6

Arranging a Stay at the Children's Inn

1.0August 2015

ADCR-7

Arranging a Stay at the Safra Lodge

1.0August 2015 

ADCR-8

New Hire Orientation

  

ADCR-9

How to Verify Human Research Protection Program (HRPP) Training

1.1 March 2014 
ADCR-10Records Managment  
ADCR-11Archiving Research Documents 1.0October 2009

ADCR-12

CCR QA Plan

1.0 September 2013
ADCR-13Clinical Center Off-Site Patient Registration 1.2July 2016
 
Administrative - Human Resources (ADHR)

SOP #

SOP Title

Version #  Version Date

ADHR-1

Research Nurse Specialist Telework 1.1 June 2015

ADHR-2

Request for Annual Leave/Scheduled Sick or Family Leave

 1.1 June 2015

ADHR-3

Research Nurse Promotion Process

 1.0 June 2015

ADHR-4

Requesting Approval for Recruiting Non-Physician Clinical Staff

 

 1.2 June 2015

 

Clinical Data Management System (CDMS)

SOP #

SOP Title

CDMS-1

Creating and Maintaining User Accounts (C3D and Labmatrix)

CDMS-2

Training Requirements and Registration Instructions (C3D, JReview, Labmatrix)

CDMS-3

Hardware/Software requirements for Accessing C3D, Lab Loader Interface, JReview and Labmatrix

CDMS-4

Protocol Build Prioritization and Build Matrix

CDMS-5

C3D Discrepancy Management

CDMS-6

C3D Change Request Submission

CDMS-7

Report Requests for JReview and Labmatrix

  

Multi-Institutional (MI)

SOP #

SOP Title

Version #Version Date 

MI-1

Multi-Institutional: General

  

MI-2

Multi-Institutional: Document Management

  

MI-3

Multi-Institutional: Participating Site Participant Registration & Status Update

1.0April 2016
  Quality Assurance Activities for C3D for Outside Sites 1.0July 2008 
MI-4 Multi-Institutional: Data Management   
MI-5 Multi-Institutional: Auditing and Monitoring   
 Protocol Management (PM)

SOP #

SOP Title

Version # Version Date 

PM-1

PI Delegation of Tasks for Research

1.2

February 2017

PM-2

Obtaining and Documenting the Informed Consent Process (Adult and Pediatric Subjects)

4.0August 2017

PM-3

Clinical Research Documentation

1.0May 2014

PM-4

Submitting Outside Record in CRIS

1.1June 2015

PM-5

Documentation of Disease Response

  

PM-6

Guidelines for Development and Maintenance of Regulatory Files/Binders

4.0January 2018

PM-7

Clinical Research Study Initiation

          Fillable Checklist

2.0November 2017

PM-8

Conducting and Documenting Drug Accountability for Oral Investigational Agents that are Self-Administered by Patients 

2.1July 2011
PM-9 

Reporting Unanticipated Problems, Deviations and Non-compliance

  
PM-10Drug Accountability - receiving, storing, dispensing (interactions with Pharmacy)  
PM-11Processing of New Information Related to Risk2.0March 2017
PM-12Responding to Theradex Clarifications 4.0April 2012 
PM-13Research Study Monitoring and Audit Visits4.0June 2016
PM-14FDA Inspections  
PM-15

Preparation of Report for SMC

1.0January 2013
 Regulatory and Protocol Support (RPS) 

SOP #

SOP Title

 Version # Version Date

RPS-1

Folder and File Name Descriptions for Electronic Regulatory Files

2.0  August 2018

RPS-2

Preparation for Scientific Review - Checklist Only

1.0 April 2012 

RPS-3

Preparation of Concept and LOI Documents

  

RPS-4

Process for Tracking NCI Protocols Reviewed by a Non-NIH IRB

1.0April 2015

RPS-5

IRB Submission and Response: New Protocol

2.0August 2018

RPS-6

Submissions to the Institutional Biosafety Committee (IBC)

2.0May 2017

RPS-7

Submissions to the Office of Biotechnology Activities (OBA)

1.0 October 2011 

RPS-8

Submitting a Protocol to the Radiation Safety Committee

1.0 April 2013 

RPS-9

Preparing Protocol Documents for eCTD Submissions to the FDA

2.0 January 2018 

RPS-10

Certificate of Confidentiality

1.0June 2013

RPS-11

Reliance Agreements

  

RPS-12

Preparation of Amendments

1.0  November 2015

RPS-13

Preparation of Continuing Reviews

1.0 December 2015

RPS-14

Submission of Personal Financial Holdings Form to the IC DEC

1.0  November 2015
RPS-15Personnel and Laboratory Updates for CCR-Sponsored Studies  
RPS-16Key Study Personnel Changes2.1 June 2018 
RPS-17

Expanded Access IND/Protocol Submissions to the FDA and IRB

1.0 November 2018 
RPS-18 Submission to the NCI Central IRB (CIRB)   
RPS-19  Requirements for NCI Clinical Director Signature2.0 June 2018
RPS-20 Study Closure 1.0November 2015
RPS-21 Establishing a Genomic Data Sharing Plan1.3August 2017
RPS-22 Requesting a Genomic Data Sharing Exception1.1August 2017
RPS-23Registering a Clinical Trial in dbGaP2.0August 2017
RPS-24

Establishing GDS Institutional Certification

1.0August 2017