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Information Blocking in a Blinded Study
Reporting Time-Sensitive Modifications
NIH Genomic Data Sharing Policy
Record Keeping Guidelines
De-identified Data Sets
FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations
Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments
External Adverse Event (AE) Reporting
Prisoners in Research
Responsibility for REP Oversight and Compliance

Institutional Review Boards (IRBMED)

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Information Blocking in a Blinded Study

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Reporting Time-Sensitive Modifications

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

NIH Genomic Data Sharing Policy

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Record Keeping Guidelines

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

De-identified Data Sets

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

External Adverse Event (AE) Reporting

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Prisoners in Research

Updated on: