Investigator Eligibility Requirements
- The NCI Formulary program does not support IND-exempt studies.
- NCI Formulary proposals will only be accepted from NCI funded main-member ETCTN and NCTN institutions in the United States and their investigators.
- Clinical trial site participants are limited to NCI funded main-member ETCTN and NCTN institutions in the United States and their investigators.
- Clinical protocols are to be conducted as single institution studies.
- NCI funded main-member ETCTN and NCTN institutions must be in good standing with an Acceptable or Acceptable Needs Follow-up Rating on their most recent NCI audit.
- NCI funded main-member ETCTN and NCTN institutions and their investigators must have resources and experience to support activities as an IND sponsor.
- NCI funded main-member ETCTN and NCTN institutions and their investigators must have funding to support clinical trial activities and provide evidence of such funding at the time of proposal submission. Clinical trial activities for these investigator-initiated trials cannot be conducted using ETCTN or NCTN funding.
- All participating investigators and sub-investigators must be registered with the NCI and maintain an active registration status.
Investigator Responsibilities
Investigator responsibilities once proposal is approved
- The study will be conducted at a single center under investigator-sponsored INDs by the requesting investigator/Cancer Center.
- NCI will transfer agents to the clinical trial sites via a clinical MTA executed between the NCI and the clinical trial site, under which Rights and responsibilities of the recipient investigator will be described.
- All serious adverse events will be submitted to the pharmaceutical company collaborators by the sponsor.
- Clinical trial data will be submitted to pharmaceutical company collaborators by the sponsor.
- Intellectual Property will be handled under the terms of the CTEP IP Option to the pharmaceutical company collaborator, with rights flowing down under the clinical MTA.
- Pharmaceutical company collaborators will have access to all data generated under the study. They will have the right to review publications, consistent with the current mechanism used in CTEP agreements.
- Neither the NCI nor the pharmaceutical company collaborators are required to provide per patient funding for the studies or any other study costs. Trial sites participating in this program are required to be able to support the full costs of the trial and they must demonstrate the source of this funding prior to protocol approval. However, if the pharmaceutical company collaborator desires to provide funding for selected aspects of the study, they may provide funds directly to the investigators or they can use the NCI CRADA mechanism to convey funding.
- Transfer of agent for preclinical work in support of clinical trials will also be facilitated under the NCI Formulary CRADA. It is anticipated by the NCI that any agent provided for clinical trials will also be made available for preclinical studies. This may be critical to the rationale and design of the clinical trial. Agents may also be available for preclinical studies only.
Forms and Templates
Letter of Intent (LOI) Template — Complete if proposing clinical research
- Submit to the Protocol Information Office (PIO) (pio@ctep.nci.nih.gov — Attention: Formulary LOI).
- Submit questions about the LOI to the NCI Formulary LOI Coordinator (pio@ctep.nci.nih.gov).
Non-Clinical Study Proposal Request Form — Complete if proposing non-clinical research
- Submit to NCIFormulary@mail.nih.gov — Subject: NCI Formulary Non-clinical Study Proposal.
- If you wish to request an AstraZeneca agent, AstraZeneca requires a company specific form. Submit request to NCIFormulary@mail.nih.gov for a copy of the form prior to the submission of the request.