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
- Available CTEP Agents Webpage
- Available CTEP Agents (Excel Spreadsheet)
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
- LOI Submission Form (MS Word)
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
- Concept Submission Form (MS Word)
- BIQSFP Information and Forms
- NCTN AYA Checklist for NCTN concepts/protocols that include Adolescent and Young Adults (AYA) (PDF)
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.
- Background and overview of the OEWG Trial Development Timelines for trial development and activation
- Timeline Reports and Study Submissions Website: Track your study’s progress through the trial development timelines and submit study documents electronically to PIO
Protocol and Informed Consent Development
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.
- Generic Protocol Template (Word) — updated July 14, 2025
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
- Generic Informed Consent Template (Word) — updated November 27, 2018
- Resource: Using Readability Tools (PDF)
- Resource: Recommendations about Attachments to the ICD (PDF)
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)
CTCAE mapping information is provided here for lead protocol organizations. Additional CTCAE documents and resources are available on the Adverse Events Reporting page.
CTCAE v6 is now available as an Excel file for lead protocol organizations. Implementation for CTEP/DCP studies is targeted for January 1, 2026 and will apply to newly opened studies only.
CTCAE Versions
- CTCAE v6 (2025) (Excel)
- CTCAE v5 (2017) (Excel)
- CTCAE v4.03 (2010) (Excel)
- CTCAE v3.0 (2006) (Excel)
CTCAE Legacy Version Mapping
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
- CTEP Simplified Disease Classification (SDC) (MedDRA v10.0) (Excel) - July 2007
- CTEP Pre-Existing Condition Codes (MedDRA v10.0) (Excel) - July 2007
- CTEP Prior Therapy Codes (MedDRA v10.0) (Excel) - July 2007
Considerations for Protocol Development and Design
Considerations for Protocol Submissions
- Active CTEP Registrations: All study personnel listed on a protocol title page must have an active CTEP registration at the appropriate level. Failure to ensure all study personnel on the title page have active registrations could delay protocol approval.
- Broadened Eligibility Criteria: CTEP's Broadened Eligibility Criteria (PDF) should be used in all CTEP-supported network trials unless there is a strong protocol-specific justification for each more stringent criterion.
- NCTN AYA Checklist: LPOs should use the NCTN AYA Checklist (PDF) for NCTN concepts/protocols that include Adolescent and Young Adults (AYA).
- NCTN Streamlined Data Practices: IND-exempt phase 3 protocols should follow the NCTN Streamlined Data Practices (PDF).
- Standard Language for Protocols Under Collaborative Agreement: Protocols under CTEP IND provided under a Collaborative Agreement must include the NCI/DCTD Standard Language for Protocols Under Collaborative Agreement (Word).
- Early Phase ETCTN Trials with Biomarkers: LPOs should refer to the Study Checklist for CTEP-Supported Early Phase Trials with Biomarker Assays (Word).
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
- DMU Complete Requirements (PDF)
- DMU Light Requirements (PDF)
| Data Element | Demography | DMU Light | DMU Complete |
|---|---|---|---|
| Patient Demographics | Yes (via OPEN) | Yes | Yes |
| On/Off Treatment Status, Adverse Events | Yes | Yes | |
| 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.
- CDUS Instructions (legacy document)
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.
- Investigators may conduct their own correlative biomarker studies with review and approval by CTEP's Biomarker Review Committee (BRC Study Checklist for LOIs).
- ETCTN Trials may request sequencing or pharmacodynamic assays through the National Clinical Laboratory Network (NCLN).
- NCTN Trials may apply for funding through the Biomarker, Imaging, and Quality of Life Studies Funding Program (BIQSFP).
- After NCTN phase 3 trials have completed and reported results, remaining specimens will be listed in the NCTN Navigator website. Investigators can submit requests for specimens directly through the NCTN Navigator site, and those requests will be reviewed by CTEP and/or by the NCTN Core Correlative Sciences Committee (NCTN-CCSC).