This form provides information on hospital staff and resources that may be involved in conducting the research project. All researchers and key personnel must complete the NIH on-line human subjects research training. Documentation of other training will be accepted in place of the on-line training. Key personnel are defined as clinical coordinators or others involved in the collection of data. The NIH on-line training is designed for NIH researchers and IRB members, but the training module is available for anyone.
Unfunded studies are eligible for fee waiver consideration.
Adverse Event Reporting Guidelines Local Serious Adverse Events Report each event to the IRB - Spokane by telephone within five days followed by a detailed letter. Briefly summarize the event in the letter and indicate if the event is related to the study drug or device. Attach to the letter a copy of either the Medwatch form or the sponsor-generated adverse event form submitted to the sponsor. A fax acknowledgement will be provided for study records. Serious Adverse Event Reports from Other Sites Forward the reports to the IRB-Spokane.