Information for Investigators

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.
Clinical Material Transfer Agreement Template (CMTA)

Investigator Responsibilities

Important details once your 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 and have the rights to review publications consistent with the current mechanism used in CTEP agreements.
Neither NCI nor 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 have the ability to support the full costs of the trial and 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 could 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 NCI that any agent provided for clinical trials would be made available for preclinical studies as well, as this may be critical to the rationale and design of the clinical trial. Agents may also be available for preclinical studies only.