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International Council for Harmonisation: Good Clinical Practice (ICH-GCP)
FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations
Certification Preparatory to Research
Limited Data Sets
Decedents
Seeking Reconsent from Research Participants
Study-Specific Adverse Event (AE) Reporting Plans
FAQ: Repository application (REP)
Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting
Adverse Event Reporting
G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Certification Preparatory to Research

Updated on:

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

Limited Data Sets

Updated on:

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

Decedents

Updated on:

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

FAQ: Repository application (REP)

Updated on:

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

Adverse Event Reporting

Updated on: