ADGC-1

Consultation by Center for Cancer Research Providers

NIH Confidentiality Agreement for Guest Clinical Observers

• Policy (sign acknowledgement at bottom):  Assuring Patient Confidentiality and Privacy at the NIH Clinical Center

Tumor/Normal Whole Exome Sequencing: Consenting, Ordering, and Obtaining Results

• iMed Resources (link updated 3/25/2024)
  • NOTE: in iMed, consents for genomic sequencing can be found under "Procedure Consents"
• Supplement A_ List of Genes for Germline Reporting
• Supplement B_English and Spanish Consents (updated July 2022)
• Supplement C_Patient Education Sheet
• Supplement D_Tumor/Normal Whole Exome Sequencing Test Referral Checklist (v. 5/8/2023) download to view checklist
• Supplement D for Hematology: Tumor/Normal Whole Exome Sequencing Test Referral Checklist: Hematology  (v. 2/8/2024)  download to view checklist
• Supplement E_Order Set Screens  (see Laboratory of Pathology CRIS Order Instructions)
• Supplement F_Family History

Outside Laboratory Genetic Test Billing and Reconciliation

ADCR-1

Sponsor Site Qualification Activities

ADCR-2

CCR Participant Registration & Status Updates

ADCR-3

How to Change a Protocol Number in CRIS (retired).  

• Please click here, log in to SharePoint and view the “Protocol Attribution” video via CRIS Education Resources

Admission, Travel, and Voucher (ATV) Process

• Guidelines for Admissions Travel Voucher (ATV) Requests  (10/2023)
• Guidelines for  Reactivating a Medical Record Number (MRN)  (10/2023)
• Guidelines for Setting your Preferences in ATV  (10/2023)
• Guidelines for  Financial Assessments and Reimbursement  (10/2023)

ADCR-5

Travel and Lodging Reimbursement for CCR Clinical Research Participants, Pediatric Guardians, and Authorized Attendants

• Internal Use Only: NCI Patient Travel Policy Clarifications for Staff

• NCI Travel and Lodging Reimbursement Handout for Patients (English version April 2024)
• NCI Travel and Lodging Reimbursement Handout for Patients (Spanish version 09/23/2022)

ADCR-6

Arranging a Stay at the Children's Inn

ADCR-7

Arranging a Stay at the Safra Family Lodge

• Medically Stable Patient Letter
• Changes to Edmund J. Safra Family Lodge Reservation Guidelines (August 24, 2023)

ADCR-8

Certifying Scanned Paper Documents

ADCR-9

Retired (June 2021)

ADCR-12

Retired (Nov 2019)

Clinical Center External Location Registration and Subsequent Activities 

• Webinar on External Location Registration (May 20, 2020, 20 minutes)

Authorization of Outside Medical Services (AOMS) for Research Participants 

• Request for Outside Medical Services Form (v. 12/13/2023)
• Slides: AOMS presentation December 2023

Replaced with ADGC-3

ADHR-1

ADHR-2

OCD and ORN Request for Annual Leave/Scheduled Sick or Family Leave

ADHR-3

Research Nurse Coordinator Promotion Process

ADHR-4

Requesting Approval for Recruiting Non-Physician Clinical Staff

CDMS-1

Change Configuration and Management Group (CCMG)

CDMS-2

Creating and Maintaining User Accounts

CDMS-3

Training Requirements

CDMS-4

Site eCRF Development, Review and Approval Process

CDMS-5

Discrepancy Management
How to Create a Manual Discrepancy in C3D (April 2020)

CDMS-6

Report Requests for JReview and Labmatrix

MI-1

Multi-Institutional:  CCR as Coordinating Center 

MI-2

Multi-Institutional: Managing Essential Documents  

MI-3

Non-NIH Site Participant Registration & Status Update

•  NCI Center for Cancer Research Participant Registration Form (January 2023)
• NCI Center for Cancer Research Participant Status Change Form (January 2023)

Multi-Institutional: Reporting Events to the NIH IRB  

• Reportable New Information (RNI) Form (v 4/14/2023)

PM-1

May 2024

PM-2

Obtaining and Documenting the Informed Consent Process (Adult and Pediatric) – General Information (Including Reconsenting, iMedConsent and Remote Consenting)

• iMed Resources (link updated 3/25/2024)
• CCR FAQs Related to Enrolling Non-English Speaking Participants (March 2024)
• OHSRP Guidelines for Enrolling Non-English Speaking Subjects (January 2024)
• OHSRP webinar related to new guidelines (February 1, 2024) Slides 
• Guidelines for Reconsenting  (May 2023)
• OHSRP Consent FAQs

April 2024

PM-2a

Obtaining and Documenting the Informed Consent Process – Adult English-Speaking participants (Including Decisionally Impaired and Enrollment of NIH Staff)

PM-2b

Obtaining and Documenting the Informed Consent Process – Adult Non- English-Speaking participants (Including Decisionally Impaired)

PM-2c

Obtaining and Documenting the Informed Consent Process – English-Speaking Children and Parents/Guardians

PM-2d

Obtaining and Documenting the Informed Consent Process – Non-English-Speaking Children and Parents (including when only the child speaks English)

PM-3

Clinical Research Documentation

• Guidelines for Entering Tumor Measurements in CRIS (May 2023)

PM-4

Submitting Outside Record for Entry in CRIS

PM-5

Research Protocol Training Requirements

• Documentation of Protocol Training - fillable, version date August 30, 2022

PM-6

Guidelines for Development and Maintenance of Regulatory Files/Binders

PM-7

Clinical Research Study Initiation  

• Fillable Checklist v6.01 (updated 01/2024)

PM-8

Conducting and Documenting Drug Accountability for Oral Investigational Products that are Self-Administered by Research Participants

•  Fillable Investigational Product Return Form

Research Team Training Requirements for IRB Modifications   

• Guidelines for Using Microsoft Forms  (v 05.07.2024)
• Modification Training Tool (v 03.11.2024)
         

Reportable Events (retired);   Please see

• • NIH HRPP Policy 801: Reporting Research Events
  • CCR M2P2s by topic Reportable Events  

NCI CTEP and Network Audits

Industry-Sponsored Studies Monitoring and Audit Visits

• CCR Supplemental Guidance for Use of NIH Box  (05/2022)
• Audit Record Request Form  (4/2021)

Center for Cancer Research Sponsored Studies Monitoring and Audit Visits

• CCR Supplemental Guidance for Use of NIH Secure Email File Transfer (SEFT) (05/2022)
• Audit Record Request Form  (4/2021)

Monitoring and Audit Visits by ASRC (Arctic Slope Regional Corporation) 

Non-NIH Laboratory Sample Management in Clinical Research Trials

Preparation of Safety Monitoring Committee (SMC) Report  (links updated 12/28/2020)

• CCR SMC Submission Template (version 02/17/2023)
• CCR SMC Accrual Table Template (version 02/17/2023)
• CCR SMC Submission Response Template (version 02/17/2023)
  

RPS-1

Folder and File Name Descriptions for Electronic Regulatory Files

Preparation for Scientific Review – see CCR Scientific Review 

Protocol PI Proxy in PROTECT

• Guidance for Assigning Protocol PI Proxy in PROTECT

RPS-3

Preparation of Concept and LOI Documents

RPS-4

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

RPS-5

NIH IRB Submission and Response: New Protocol 

RPS-6

Submissions to the Institutional Biosafety Committee (IBC)

RPS-7

Submissions to the Office of Biotechnology Activities (OBA)

RPS-8

Submissions to the Radiation Safety Committee  

RPS-9

Preparing Protocol Documents for eCTD Submissions to the FDA

RPS-10

Retired (May 2023)

RPS-11

Reliance Agreements

RPS-12

NIH IRB Submission of Amendments  

RPS-13

Preparation of Continuing Review or Progress Report   

RPS-14

Submission of Personal Financial Holdings Form to the Institute/Center Deputy Ethics Counselor

Expanded Access IND/Protocol Submissions to the FDA and IRB  

see M2P2 #70: What is an Expanded Access Use IND/IDE (also called “Single Patient” or “Compassionate Use”?

Establishing a Data Management and Sharing Plan

• DMSP Submission Portal User Manual (v. 8/28/2023)

Requesting a Data Management and Sharing Waiver