Material Transfer Agreements, Packaging and Shipping



Attachment 5 - Material Transfer Agreements, Packaging and Shipping Checklist

Distribution and agreements

Self-audit/review assistance

• Undertaking a review of a sampling of Material Transfer Agreements (MTAs).

• Review the end-user distribution SOP.

• Identify who ensures that the MTA includes all the required information.

• Review and describe the MTA process.

|1. |MTA criteria |Y/N/NA |

| |MTAs define the rights and obligations of the provider (research biorepository) and recipient (researcher), including | |

| |allowable uses for the specimen and/or data once transferred. | |

|2. |MTA areas covered |Y/N/NA |

| |The MTA addresses each of the following areas as applicable. | |

| |1. Future distribution of modifications and derivations made by the recipient. | |

| |2. Documentation of each participant's role in the modifications or derivations. | |

| |3. Terms of confidentiality. | |

|3. |End-user distribution SOP criteria |Y/N/NA |

| |The distribution SOP includes confirmation that the end-user has Human Research Ethics Committee (HREC) approval or there | |

| |is an MTA in place that provides relevant assurance for the appropriate use of the biospecimen according to appropriate | |

| |ethical and legal requirements. | |

| |Evidence of compliance: | |

| |✓ Copies of HREC approvals from end-users OR copies of MTA agreements | |

|Completed by:__________________________________________________________________ |

|Date: _________________________________________________________________________ |

Adapted from National Cancer Institute NCI Best Practices for Biospecimen Resources Biorepository Checklist.

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download