For New Study Design/Protocol Submissions (Sponsor/CRO)
The following documents are required for a new study design/protocol submission:
- New Study Submission Application (signed by an individual authorized to act in an official capacity for the Sponsor/CRO)
- For Device Studies: Submit one of the following:
- FDA Investigational Device Exemption (IDE) Letter verifying the IDE number for the proposed use (if this is not provided, a protocol from the Sponsor imprinted with the IDE number for the proposed use must be provided)
- FDA Letter granting 510k clearance for the device
- FDA pre-market approval (PMA) Letter (with supplement/amendment letters) pertinent to this device application
- Letter from Sponsor assessing how/why the device is a non-significant risk (NSR) device
- Letter from Sponsor explaining why the device study is exempt from IDE requirements pursuant to 21 CFR 812.2(c)
- New Study Submission Application Form Attachments, if applicable (i.e., SIRB Authorization Agreement, copy of Federal grant and/or contract, Federalwide Assurance, Study-Related/Retention Materials, Certification Letter from Professional Translation Service, etc.).
- Study Protocol (complete DHHS-approved protocol, where this exists)
- Sub-Study materials and documentation, if applicable
- Proposed Consent Document(s) (DHHS-approved sample consent document, where this exists) (electronic format preferred)
- Copy of Proposed study-wide Recruitment Materials and Study-Related/Retention Materials (instructions, diaries, etc.)
- Investigator’s Drug Brochure or package insert (if applicable)
- Manual of Operations / Instructions for Use – Device Studies (if not a part of the protocol)
For New PI/Site Submissions (Principal Investigator)
The following documents are required for submission of Principal Investigators, either concurrent with the protocol or as a later amendment to the study (for protocols for which Sterling IRB is the central IRB):
- Submission Application for the Investigator/Site (signed by the Principal Investigator).
- Submission Application for the Investigator/Site Attachments, if applicable (i.e., FDA 483(s), training certificates, compensation schedule, site SOPs pertaining to the informed consent process, Site-Specific recruitment materials, Financial Disclosure Forms, etc.).
- Supplemental Site Form(s) with Attachments, if applicable.
- Curriculum Vitae of the Principal Investigator and Sub-Investigator(s) (include a list of previous clinical research experience and publications).
- Copy of Principal Investigator’s current medical license with expiration date (wallet card acceptable).
- Copy of Principal Investigator’s DEA Registration (if applicable).
- Copy of FDA Form 1572 (if applicable).
For Amendment to Add/Change Research Site for Previously-Approved
Principal Investigator
The following documents are required to request an amendment to add an additional research site, or to replace an existing research site, for a Principal Investigator who has already received IRB approval:
- Add or Change Site Submission Application (signed by the Principal Investigator).
- Add or Change Site Submission Application Attachments, if applicable (i.e. IRB Release Letter, FDA 483(s)).
- Copy of revised FDA Form 1572 (if applicable).
For Amendment to Change Principal Investigator
The following documents are required to request an amendment for a change of Principal Investigator:
- Submission Application for Change of Principal Investigator (signed by Principal Investigator)
OR
Submission Application for the Investigator/Site (signed by Principal Investigator)
plus Supplemental Site Form(s) (if applicable).
- Submission Application for Change of Principal Investigator Attachments
OR
Submission Application for the Investigator/Site Attachments
- Curriculum Vitae of the new Principal Investigator (include a list of previous clinical
research experience and publications).
- Copy of Principal Investigator’s current medical license with expiration date (wallet
card acceptable).
- Copy of Principal Investigator’s DEA Registration (if applicable).
- Copy of new FDA Form 1572 (if applicable).
For Other Types of Amendments to Previously Approved Research
The following documents are required to request an amendment to previously approved research:
- Modifications and Amendments Submission Form
OR
- Screening Script Submission Form.
For New Registry Study Design/Protocol Submissions (Sponsor/CRO)
The following documents are required for a new registry study design/protocol submission:
- New Study Submission Application (signed by an individual authorized to act in an official capacity for the Sponsor/CRO).
- New Study Submission Application Attachments, if applicable.
- Study Protocol.
- Sub-Study materials and documentation, if applicable.
- Proposed Consent Document(s), if applicable (electronic copy preferred).
- Copy of Proposed study-wide Recruitment Materials and Study-Related/Retention Materials (instructions, diaries, etc.).
For New Registry Study PI/Site Submissions (Principal Investigator)
The following documents are required for submission of Principal Investigators, either concurrent with the protocol or as a later amendment to the registry study (for protocols for which Sterling IRB is the central IRB):
- Registry Study Submission Application for the Investigator/Site (signed by the Principal Investigator).
- Registry Study Submission Application for the Investigator/Site Attachments, if applicable (i.e., FDA 483(s), IRB Release Letter, Financial Disclosure Forms, etc.).
- Registry Study Supplemental Site Form(s) with Attachments, if applicable.
- Curriculum Vitae of the Principal Investigator and Sub-Investigator(s) (include a list of previous clinical research experience and publications).
- Copy of Principal Investigator’s current medical license with expiration date (wallet card acceptable).
- Copy of Principal Investigator’s DEA Registration (if applicable).
- Copy of FDA Form 1572 (if applicable).
For Amendment to Add/Change Research Site for Previously-Approved Registry Study Principal Investigator
The following documents are required to request an amendment to add an additional research site, or to replace an existing research site, for a Principal Investigator who has already received IRB approval for a registry study:
- Registry Study Additional Site Submission Application (signed by the Principal Investigator).
- Registry Study Additional Site Submission Application Attachments, if applicable (i.e. IRB Release Letter, FDA 483(s)).
- Copy of new FDA Form 1572 (if applicable).
For Amendment to Change Registry Study Principal Investigator
The following documents are required to request an amendment for a change of Principal Investigator for a registry study:
- Registry Study Submission Application for Change of Principal Investigator (signed by
Principal Investigator)
OR
Registry Study Submission Application for the Investigator/Site (signed by Principal
Investigator) plus Registry Study Supplemental Site Form(s) (if applicable).
- Registry Study Submission Application for Change of Principal Investigator Attachments
OR
Registry Study Submission Application for the Investigator/Site Attachments
- Curriculum Vitae of the new registry study Principal Investigator (include a list of previous clinical research experience and publications).
- Copy of registry study Principal Investigator’s current medical license with expiration date (wallet card acceptable).
- Copy of registry study Principal Investigator’s DEA Registration (if applicable).
- Copy of new FDA Form 1572 (if applicable).
For Continuing Review
The following documents are required to request study continuation:
- Sponsor Continuing Review Status Report (signed by the Sponsor)
AND
Site Continuing Review Status Report (signed by the Principal Investigator)
OR
Abbreviated Site Continuing Review Status Report
OR
- Single-Site Continuing Review Status Report (signed by the Sponsor-Investigator)
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