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Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents

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DAIDS Use of Study Products Not Marketed in the United States Policy Frequently Asked Questions

This section provides answers to the frequently asked questions (FAQs) regarding the DAIDS Use of Study Products Not Marketed in the United States Policy:

When does the “Use of Study Products Not Marketed in the United States” policy apply?

This policy applies when a protocol specifies that a particular study product will be used, but the study does not supply the product. In this case, study participants will need to obtain the product locally. The goal of this policy is to help ensure that such locally-sourced products are safe, and do not negatively impact the scientific integrity of the study.

If the study product is being provided as part of the trial, does this policy apply?

No. In that situation, it is up to those responsible for the conduct of the study to ensure that the supplied study products meet appropriate standards.

Would an “herbal” supplement need to qualify? Is this policy intended to only apply to therapies for HIV, tuberculosis, and malaria? What about non-prescription drugs?

This policy applies to all drugs, biologics, vaccines, or devices that are identified in the protocol as study required products, regardless of whether a prescription is required. However, the term does not include concomitant medications, medications specified in the protocol for the treatment of adverse events, or products that are not approved in the country in which they will be used.

If a study agent meets the criteria listed in Section 6.1.1, does the site investigator still need to submit the information listed in Section 6.1.2 to obtain approval?

No. If the site investigator determines that the study product to be obtained locally meets the criteria listed in Section 6.1.1, no further approval is required.

If all of the information listed in Section 6.1.2 is not available, can a study product still be approved?

Yes. All of the requested information that can be obtained should be submitted, and a determination will be made regarding approval as per the policy.

Last Updated April 18, 2012

Last Reviewed April 18, 2012