Forms, Documents, Templates...
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| Title | Description | Category |
|---|---|---|
| "To Whom it May Concern" (Letter for Sponsors Regarding Adverse Events
|
AE Letter for Spnsors | IRB—Institutional Review Board (Human Subject) |
| Access to Patient Information for Research Purposes: Demystifying the Process
|
Educational Presentation | IRB—Institutional Review Board (Human Subject) |
| Adult & Minor Subjects Signature Page Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Adult Subjects Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Adult Subjects Signature Page Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Adult and/or Minor Subjects Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Adverse Event Guideline
|
Requirements for notifying the IRB of Unanticipated Events | IRB—Institutional Review Board (Human Subject) |
| Amended Informed Consent Regulations (FDA)
|
Amended informed consent regulations (FDA) | IRB—Institutional Review Board (Human Subject) |
| Assessing Capacity to Consent for Research
|
Form | IRB—Institutional Review Board (Human Subject) |
| Banking Specimens Section Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Bosnian Language HIPAA Section
|
HIPAA section translated into Bosnian | IRB—Institutional Review Board (Human Subject) |
| Bosnian Language Signature Pages
|
Signature pages translated into Bosnian | IRB—Institutional Review Board (Human Subject) |
| Bosnian Language Standard Consent Sections
|
In Case of Injury, Questions, Voluntary Participation, etc. translated in to Bosnian | IRB—Institutional Review Board (Human Subject) |
| CITI Education Requirement Policy
|
Mandatory Human Subjects Education Program | IRB—Institutional Review Board (Human Subject) |
| Case Reports Using Existing Data - Author Worksheeti
|
Case Report Guide | IRB—Institutional Review Board (Human Subject) |
| Conflict of Interest Policy for IRB Members
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Emergency Use Report Formi
|
Form | IRB—Institutional Review Board (Human Subject) |
| Emergency Use of Unapproved Medical Devices
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Emergency Use of an Investigational Drug or Biologic
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| FDA Guidance on Consent for the use of In Vitro Diagnostics
|
Guidance | IRB—Institutional Review Board (Human Subject) |
| FDA Guidance on In Vitro Diagnostics
|
Guidance | IRB—Institutional Review Board (Human Subject) |
| Genetic Testing & Banking Adults Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Genetic Testing & Banking Adults and Children Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Genetic Testing: Understanding Definitions and Key concepts
|
Education | IRB—Institutional Review Board (Human Subject) |
| Guidelines for Genetic Testing
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Guidelines for Scientific Reviewers
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| HIPAA Required Section Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| HIPAA Required Section Spanish Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| HIPAA Review Prepatory to Research Request Form
|
Form | IRB—Institutional Review Board (Human Subject) |
| HIPAA and Research
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| How to Register for the CITI Basic or Refresher Course
|
Step by step instructions on registering for the CITI Basic or Refresher Course | IRB—Institutional Review Board (Human Subject) |
| IRBNet New User Registration and instruction document
|
IRBNet New User Registration and instructions | IRB—Institutional Review Board (Human Subject) |
| IRBNet Training Energizer 1
|
IRBNet Training Energizer 1 | IRB—Institutional Review Board (Human Subject) |
| IRBNet Training Energizer 2
|
IRBNet Training Energizer 2 | IRB—Institutional Review Board (Human Subject) |
| In Vitro Diagnostocs Decision Tree
|
Guidance | IRB—Institutional Review Board (Human Subject) |
| Investigator 101 Education Material
|
Education Material | IRB—Institutional Review Board (Human Subject) |
| Investigator Responsibilities for Research Involving a Significant Risk Device
|
Guidance | IRB—Institutional Review Board (Human Subject) |
| Meeting Dates and Deadlines
|
Dates and Deadlines | IRB—Institutional Review Board (Human Subject) |
| Minor Subjects Only Signature Page Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| NCI CIRB Contact Information
|
Form | IRB—Institutional Review Board (Human Subject) |
| NCI CIRB Study Closure Information Formi
|
Form | IRB—Institutional Review Board (Human Subject) |
| NCI Central IRB (CIRB) Guidelines
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Parental Permission Only Consent Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Pharmacy Research Policy
|
Pharmacy Research Policy | IRB—Institutional Review Board (Human Subject) |
| Policy on IRB Review for Studies Pending Funding
|
Policy | IRB—Institutional Review Board (Human Subject) |
| Reporting of Protocol Deviations
|
Protocol Deviation Policy | IRB—Institutional Review Board (Human Subject) |
| Request Exemption from IRB Review
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Request for Tissue for Research Purposes (Pathology Department Form)i
|
Form | IRB—Institutional Review Board (Human Subject) |
| Requesting an IND Consult from the FDA
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Research on Decedent's Information Requesti
|
Form | IRB—Institutional Review Board (Human Subject) |
| SOP for Establishing Legal Guardianship for Pediatric Subjects
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| SOP for Obtaining Consent from Subjects who Enrolled as a Minor
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Sample Assent Form
|
Form | IRB—Institutional Review Board (Human Subject) |
| Security of Research Data: How to Protect Research Subjects
|
Overview of relevant FDA guidelines, HIPAA Security, and State Law; best practices to follow for protecting electronic information | IRB—Institutional Review Board (Human Subject) |
| Spanish Language Version Signature Page Template
|
Template | IRB—Institutional Review Board (Human Subject) |
| Spanish Lanuage Standard Consent Sections
|
Standard language for the 'In Case of Injury', 'Questions', and 'Voluntary Participation' sections | IRB—Institutional Review Board (Human Subject) |
| The Impact of The HIPAA Privacy Rule on Research
|
Educational Presentation | IRB—Institutional Review Board (Human Subject) |
| Unanticipated Problems and Adverse Event Flow Chart
|
Determination Flow-chart | IRB—Institutional Review Board (Human Subject) |
| University Hospital Patient Data Request Form
|
Form | IRB—Institutional Review Board (Human Subject) |
| University Hospital, Voluntary Faculty Request to Conduct Research which Requires the Use / Disclosure of IIHIi |
Form | IRB—Institutional Review Board (Human Subject) |
| Upstate IRB Guidelines & Policies
|
Guidelines/Policies | IRB—Institutional Review Board (Human Subject) |
| Volunteer Recruitment Formi
|
Form | IRB—Institutional Review Board (Human Subject) |
| Waiver of Authorization Request Formi
|
Form | IRB—Institutional Review Board (Human Subject) |