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The Pennsylvania Code website reflects the Pennsylvania Code changes effective through 52 Pa.B. 6342 (October 1, 2022).

28 Pa. Code § 1211.31. Renewal of approval of a clinical registrant.

§ 1211.31. Renewal of approval of a clinical registrant.

 (a)  The term of an approval of a clinical registrant will coincide with the term of the clinical registrant’s grower/processor permit and dispensary permit.

 (b)  An approved clinical registrant shall renew its approval as part of the renewal for a grower/processor permit and a dispensary permit under §  1141.36 (relating to permit renewal applications). The renewal application must be on a form prescribed by the Department and include all of the following:

   (1)  A copy of the research contract.

   (2)  A list of the approved research programs or research studies that are continuing or, if any of them are concluded, the dates they were concluded.

   (3)  A report of the current status of active research programs or research studies being conducted under the research contract, including preliminary findings, if applicable, and any expectations and projections the approved clinical registrant and the certified ACRC have for future research programs or research studies over the course of the 2 years following the date of submission of the report.

   (4)  A description of proposed research programs or research studies covered by the research contract that the approved clinical registrant intends to conduct within the next year following submission of the renewal application including evidence of IRB approval for each research program or research study.

   (5)  A statement that a false statement made by the approved clinical registrant or the certified ACRC is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).

   (6)  Any other information deemed necessary by the Department.

 (c)  The Department will not renew an approval for a clinical registrant under this section if the Department determines that none of the dispensary locations under the dispensary permit held by the approved clinical registrant are participating in an approved research program or research study and the approved clinical registrant does not intend to begin any additional approved research programs or research studies within the first 6 months following the approval of its application for renewal.

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