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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

Developing and Maintaining Standard Operating Procedures

 1.0 March 2015

ADCR-2

Participant Registration & Status Updates

 2.0 April 2016

ADCR-3

How to Change a Protocol Number in CRIS

  
ADCR-4Admission, Travel, and Voucher Process  

ADCR-5

Reimbursing Healthy Volunteers

  

ADCR-6

Process for Staying at Children's Inn

 1.0August 2015

ADCR-7

Process for Staying at the Safra Lodge

 1.0August 2015 

ADCR-8

New Hire Orientation

  

ADCR-9

How to Verify Human Research Protection Program (HRPP) Training

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

ADCR-12

CCR QA Plan

  
 ADCR-13Off-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/Unscheduled Leave, 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

 1.0 

MI-2

Multi-Institutional: Document Management

 1.0 

MI-3

Multi-Institutional: Participating Site Participant Registration & Status Update

 1.0April 2016
  Quality Assurance Activities for C3D for Outside Sites   
MI-4 Multi-Institutional: Data Management  1.0 
MI-5 Multi-Institutional: Auditing and Monitoring  2.0 
 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

 1.0 May 2014

PM-4

Submitting Outside Record in CRIS

 1.1 June 2015

PM-5

Documentation of Disease Response

  

PM-6

Guidelines for Development and Maintenance of Regulatory Files/Binders

 3.0 October 2017

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 Risk 2.0 March 2017
PM-12Responding to Theradex Clarifications   
PM-13Research Study Monitoring and Audit Visits 4.0 June 2016
PM-14FDA Inspections  
PM-15

Preparation of Report for SMC

  
 Regulatory and Protocol Support (RPS) 

SOP #

SOP Title

 Version # Version Date

RPS-1

Nomenclature for Protocol Documents and Protocol Files and Folders

  

RPS-2

Preparation for Scientific Review - Checklist Only

  

RPS-3

Preparation of Concept and LOI Documents

  

RPS-4

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

 1.0 April 2015

RPS-5

IRB Submission and Response: New Protocol

 1.0 September 2015

RPS-6

Submissions to the Institutional Biosafety Committee (IBC)

 2.0 May 2017

RPS-7

Submissions to the Office of Biotechnology Activities (OBA)

  

RPS-8

Submitting a Protocol to the Radiation Safety Committee

  

RPS-9

Submissions to FDA (CDER and CBER)

  

RPS-10

Certificate of Confidentiality

  

RPS-11

Reliance Agreements

  

RPS-12

Preparation of Amendments

  November 2015

RPS-13

Preparation of Continuing Reviews

  December 2015

RPS-14

Submission of Personal Financial Holdings Form to the IC DEC

  November 2015
RPS-15Central Regulatory File  
RPS-16FDAAA  
RPS-17Expanded Access  
RPS-18 Submission to the NCI Central IRB (CIRB)   
RPS-19  Requirements for NCI Clinical Director Signature1.0 December 2017 
RPS-20 Study Closure  1.0November 2015
RPS-21 Establishing a Genomic Data Sharing Plan 1.3August 2017
RPS-22 Requesting a Genomic Data Sharing Exception 1.1August 2017
RPS-23Registering a Clinical Trial in dbGaP 2.0August 2017
RPS-24

Establishing GDS Institutional Certification

 1.0August 2017 
Last updated by Grady, Deborah (NIH/NCI) [E] on Dec 07, 2017