Forms and templates are needed at all stages of study start up and conduct. In the sections below, forms are grouped based on the status of the study. Because regulatory documentation can vary from study to study, contact us for detailed information on which forms to use for your particular situation.
Industry Sponsorship Form
Fred Hutch industry supported research studies only (industry-sponsored clinical trial agreements, investigator-initiated study agreements, clinical material transfer agreements, and clinical drug transfer agreements for drug/device/biologics used in humans in clinical research). Gives basic Industry Sponsor information prior to the draft contract.
*Before submitting an Industry Sponsorship Form for a CTA, please complete the New Study Submission Form in OnCore CTMS to obtain the RG number for the protocol. https://www.seattlectms.org
Confidential Disclosure Agreement/Nondisclosure Agreement
Confidential disclosure agreements related to Fred Hutch clinical research studies
Fred Hutch subcontracts off an industry-supported clinical research agreement or industry-supported non-clinical research agreement.
Amendments to industry-supported clinical research agreements, confidentiality agreements, and subcontracts that are run through Fred Hutch.
For FH based contracts only; internal routing and approval process for all industry supported research agreements to activate project funding budget after contract execution and IRB approval. Questions about the internal budget activation process for industry sponsored studies at Fred Hutch can be routed to CRSpostaward@fredhutch.org.
Internal routing and approval process for all industry supported research agreements, FH contracts only in order to activate the study funding budget at FH.
CRS has also developed a collection of templates that study teams can use to improve study documentation and show appropriate PI oversight of investigations. These templates -- which can be downloaded from the Clinical Research Resources Website and customized to the requirements of your protocol -- may be used for both investigator-initiated and industry-sponsored studies when equivalent forms are not provided.
The following Study Tools (in addition to many others) can be found* under the "Study Management" section of the CRRW:
- Adverse Event Log
- Central Startup Checklist for Fred Hutch and UW
- Contact Log
- CRS CV Template
- Delegation of Authority Log
- FDA Submission Tracking Log
- ICF Discussion Documentation
- Manual of Procedures
- Note to File Template
- PI on Leave NTF
- Protocol Template - Solid Tumor
- Protocol Template - Transplant
*Consortium members with HutchNet IDs automatically have access to the site. Other Consortium research staff associated with our partner institutions needing access to the site should email Clinical Research Support to have a profile created.
All FDA forms listed below may be downloaded directly from the FDA Forms website. The site also includes instructions and/or guidance for each of the forms referenced.
The most frequently used FDA forms associated with investigator-sponsored INDS are:
- Form FDA 1571, "Investigational New Drug Application"
- Form FDA 1572, "Statement of Investigator"
- Form FDA 3500A, MANDATORY MedWatch Reporting
(Please note: This is not the same as Form FDA 3500, VOLUNTARY MedWatch Reporting)
- Form FDA 3674, "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank"