Sponsor information regarding COVID-19
The guidelines below apply ONLY to IRP investigators.
March 12, 2020
Guidance from ORSC regarding IND Sponsor required communication and planning for use of non-NIH facilities
To be used if NIH ORSC is the IND sponsor of the study.
March 16, 2020
Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP)
March 24, 2020
Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program (CTEP) and NCI Community Oncology Research Program (NCORP) Affected by the Spread of the Novel Coronavirus
March 31, 2020
Non-NIH Facility Information Form
To be used if ORSC is the IND sponsor of the study. This form is used to document the non-NIH facility that is being asked to accept a participant under a NIH protocol interest and capacity in performing and capacity protocol-related procedures and medical testing.
March 31, 2020
Plan for Use of Qualified Non-NIH Facility
To be used if ORSC is the IND sponsor of the study. This form should be completed and signed by the NIH Principal Investigator to document intent to use a qualified non-NIH facility for protocol-related procedures and medical testing. In addition to completing all items, please provide related documentation as specified.
March 31, 2020
CCR IND Sponsor required communication and planning for use of non-NIH facilities
Instructions for CCR Sponsored studies
April 15, 2020
IND Sponsor required communication and planning for using telemedicine
Overview
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