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

Secondary Use Research

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

Retention of Research Data/Biospecimens

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

Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements

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

Quality Assurance and Quality Improvement (QA/QI) Projects

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P
Policies
High-level program plans that outline the general goals and acceptable procedures for a unit.
Policies

Statement of Practice: HIPAA and U-M study team members outside Michigan Medicine in eResearch applications

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

Multi-Site and Performance Site applications: Reporting to IRBMED

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I
Informational
Informational tools to help guide you through specific tasks.
Informational

Guidance for Writing HUM Applications for Creating a Biorepository at the CBR

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I
Informational
Informational tools to help guide you through specific tasks.
Informational

Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR

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P
Policies
High-level program plans that outline the general goals and acceptable procedures for a unit.
Policies

Statement of Practice: Ancillary Approval & Final IRBMED Approval

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P
Policies
High-level program plans that outline the general goals and acceptable procedures for a unit.
Policies

Statement of Practice: IRBMED Communication Methods for Study Teams

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P
Policies
High-level program plans that outline the general goals and acceptable procedures for a unit.
Policies

Statement of Practice: IRBMED Finalization of Study Documents

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P
Policies
High-level program plans that outline the general goals and acceptable procedures for a unit.
Policies

Statement of Practice: eResearch Cross-Reference Table

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P
Policies
High-level program plans that outline the general goals and acceptable procedures for a unit.
Policies

Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control

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

Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting

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

Study-Specific Adverse Event (AE) Reporting Plans

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