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Lead Organizations: Developing and Conducting NCI Network Trials

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Welcome to our new website. Download our one-page PDF guide for quick links to frequently accessed materials.

Network Clinical Trial Site?

Click here for the new site resources landing page.  

Looking for the Adverse Event Reporting Guidelines or CTCAE?

Click here for the new site-focused adverse events page. 

Resources for Lead Protocol Organizations

CTEP resources are used by investigators and lead protocol organizations (LPOs) in networks across NCI to develop and conduct clinical trials. 

CTEP Agents and Agreements

After NCI has a signed Collaborative Research and Development Agreement (CRADA) to develop and evaluate an agent under CTEP IND, the agent will be added to the List of Available CTEP Agents for qualified investigators to propose pre-clinical and clinical research studies. 

Available CTEP Agents

Industry Collaborations and Guidelines

CTEP has developed guidelines for the conduct of clinical trials under a collaborative agreement with a pharmaceutical or biotech company partner.  The Lead Protocol Organization is responsible for ensuring compliance with these guidelines, including publication review, data access and data sharing, and intellectual property licensing. 

More information about the CTEP Intellectual Property Option (CTEP IP Option) and model CRADAs, confidential disclosure agreements, and MTAs are available on the CTEP IP Option and Agreements page.

Network-Specific Information

PEP-CTN: Proposals for prioritization of an agent may be submitted to the PEP-CTN Agent Prioritization Committee from PEP-CTN members, COG Disease Committees, other academic research teams, and pharmaceutical companies using the PEP-CTN Agent Prioritization (AP) Proposal form (Word). Questions about the AP Proposal form and requests for a Pre-Review Meeting can be addressed to: NCI-PEP-CTN@nih.gov. Consultation prior to submission of an AP Proposal form is encouraged.

LOI and Concept Development

Letters of Intent (LOIs)

LOIs for small cancer treatment trials using available CTEP IND agents can be submitted to the CTEP Protocol Information Office (PIO) by the grantee organization in the ETCTN, NCTN, PBTC, PEP-CTN, and AMC (US-only trials). 

NCTN, PBTC, and PEP-CTN grantees can also submit LOIs proposing use of agents under their IND or for IND exempt trials. 

Early-career investigators in the ETCTN and NCTN are encouraged to learn about applying to the Career-Development LOI (CRDL) program for priority consideration.

LOI Form

Concepts

NCTN Groups can submit concepts proposing larger cancer treatment trials to PIO. When there is an appropriate integral endpoint that needs additional support, a BIQSFP (Biomarker, Imaging, and Quality of Life Studies Funding Program) application can be submitted at the same time. BIQSFP applications for real-time integrated endpoints should be submitted after a concept has been approved. 

Concept Form and Checklist

CTEP Trial Development Timelines

CTEP's trial development timelines ensure that promising new therapies can reach patients without undue delays. Investigators may track their study’s progress online, and CTEP staff work with investigators and collaborators during development to overcome obstacles to protocol approval and activation.

Protocol Development

After an LOI or Concept is approved, the lead organization works on developing the trial protocol and informed consent based on the approved trial designs. 

Additional notes for protocol design and considerations are below.

ETCTN Protocol Template

The ETCTN has support from CTEP's Central Protocol Writing Service (CPWS) to write these documents. CTEP's protocol template is required for protocols in the ETCTN under CTEP IND.

Informed Consent Documents

CTEP provides an Informed Consent Template for use in all NCI-supported network trials reviewed by the NCI CIRB. 

Informed Consent Template and Resources

Informed Consent Side Effect Tables

CTEP also provides resources and information for the tables of side effects included in the CTEP Informed Consent Template: Side Effect Tables for CTEP Informed Consent Documents (html)

At this page, you can find resources for developing side effect tables to use in the CTEP Informed Consent Template and download CTEP-provided lists of side effects for commonly-used commercially-available cancer treatment drugs and regimens. 

CTCAE and CTEP Codes

Common Terminology Criteria for Adverse Events (CTCAE)

The current version of CTCAE is CTCAE v5.0, released in 2017. CTEP expects to release CTCAE v6.0 in the coming year. CTCAE mapping information is provided here for lead protocol organizations. Additional CTCAE documents and resources are available on the Adverse Events Reporting page. 

CTCAE Versions and Resources

Additional Codes

The below codes and links are provided as a resource for reporting and analysis for CTEP-supported trials.

Site Codes and Agent Codes - updated weekly on the CTEPcore website

Additional Codes

Considerations for Protocol Development and Design

Considerations for Protocol Submissions

CTEP Data Monitoring Methods and Data Reporting Responsibilities

The required data monitoring method will be communicated at the time of LOI or concept approval.  Data Mapping Utility (DMU) reporting, either DMU Complete or DMU Light, is used for protocols under CTEP IND that require enhanced monitoring. 

Requirements for DMU Complete and DMU Light reporting 

Overview of Data Elements Required by Monitoring Method 
(as applicable for a particular protocol)
Data ElementDemographyDMU LightDMU Complete
Patient Demographics Yes 
(via OPEN)		YesYes
On/Off Treatment Status, Adverse Events YesYes
Treatment and Course Information Yes
 (abbreviated)		Yes
Baseline Abnormalities, Dosing Information, Late Adverse Events, Response Data  Yes

Protocols that preceded the Data Mapping Utility may still be using CDUS reporting. The CDUS Instructions are provided for these legacy trials.  

Patient Drug Interactions Handout and Wallet Card

A Patient Drug Interactions Handout and Wallet Card must be provided as a protocol appendix for a trial of a non-marketed agent that has potential drug interactions.  

  • For studies under CTEP IND, the Handout and Wallet Card will be authored by CTEP PMB.
  • For studies not under CTEP IND, the lead protocol organization is responsible for authoring the Handout and Wallet Card.
  • Additional patient-specific fields in the Handout and Wallet Card are to be filled out by the site with the appropriate information for each patient. 

Template and Instructions for Trials of Non-Marketed Agent(s) with Potential Drug Interactions: CTEP Patient Drug Interactions Handout and Wallet Card (Word)

After Trial Activation

After a CTEP-supported network trial activates, CTEP continues to monitor and support the trial in different ways. 

Protocol Amendments

After CTEP has provided approval on hold or approval of a protocol document, each subsequent protocol amendment submission should include a summary of changes since the last CTEP-approved protocol. 

Summary of Protocol Changes (Word)

Trial Status Updates

Credentialed staff from the lead protocol organization should make trial status updates directly in the CTSU Protocol Application for all protocol statuses from initial activation to FDAAA/IRB Complete. 

The only status that can be set by PIO upon request from the LPO is the final Administratively Complete status. 

Slow Accruing Trials

Enrollment to CTEP network trials is monitored to ensure it is meeting the projected accrual rates that were reviewed and approved as part of the trial development. Trials that are significantly below their projected accrual rates may not be able to complete enrollment in a reasonable timeframe.  The CTEP Slow Accrual Guidelines describe how CTEP will evaluate accrual and what actions CTEP will require for slow-accruing trials. These actions may include:

  • Corrective action plans
  • Amendments to enhance enrollment or redesign the trial to meet a more realistic accrual goal
  • Termination of a trial that is not expected to complete enrollment

CTEP Slow Accrual Guidelines

Lead Protocol Organization Responsibilities for ClinicalTrials.gov Registration and Results Reporting 

ClinicalTrials.gov registration and results reporting is required by law (Section 801 of the Food and Drug Administration Amendments Act, commonly called FDAAA, and the Final Rule) and NIH policy (the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information) for CTEP-supported clinical trials. 

The Lead Protocol Organization (LPO) is responsible for ensuring the trials they lead are in compliance with FDAAA 801, the Final Rule, and the NIH policy requirements for clinical trials registration and results reporting. This includes trials under CTEP IND. 

Lead Protocol Organization Responsibilities and Processes for ClinicalTrials.gov Registration and Results Reporting for CTEP-Supported Clinical Trials (PDF) - June 2025

Ancillary Correlative and Biomarker Studies

Investigators are encouraged to include judicious and evidence-based correlative study proposals in their LOI and protocol designs. These may be investigator-led, or may take advantage of one of NCI’s biomarker development initiatives.

  • Updated:

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