Acadia IIS Process
Phase I: Submission of a Concept Proposal
In order to submit a Concept, Applicants must first complete registration and submit current curriculum vitae (CV). This must be done via the Acadia IIS application portal:
Next, Applicants must fill out the Concept Proposal page. The general information provided during the registration process will be used to pre-populate certain fields in the Concept page. Applicants are required to provide the following information related to the proposed
Title of proposal
Type of support requested (financial and/or product)
Study rationale and explanation of unmet medical need
Study population (clinical studies)
Feasibility of enrolling proposed population (clinical studies)
Description of the unique or novel feature of the Study
All Concept Proposals must be submitted via the Acadia online IIS application portal. Hard copies will not be accepted.
Review and Approval of Concept Proposals
The Acadia Independent Investigators Studies (IIS) Review Committee will review all Concept Proposals for scientific merit, innovation, clinical importance/potential impact on patients, and compliance with company policy and requirements. The Review Committee will extend contingent approval* to certain Applicants to proceed to the second step of the process, which is submission of a detailed Protocol. Applicants will be notified of the Review Committee's decision via email and the status will also be available on the portal.
Phase II: Submission of an Investigator Initiated Study Protocol
Once the Applicant has been granted contingent approval of the Concept Proposal, Applicants may submit their Protocol. All Protocols must be submitted via the Acadia online IIS application portal within 6 weeks of approval of the Concept Proposal. Hard copies will not be accepted. Protocols are reviewed at the next available IIS Review Committee meeting
All expenses associated with the research must be identified in the detailed study budget of the application. The amount of all expenses must not exceed fair market value of the expenses associated with the research. All payments must be milestone-based and not based on final results. In addition, payment shall not be made in one lump sum prior to the start of research. Instead, payment will be spread out based on milestones achieved.
Investigator Initiated Study Agreement
Applicants whose Protocol is approved will be sent an Acadia Investigator Initiated Study Agreement which will set forth the obligations with respect to the study.
Acadia requires Investigator Initiated Study Recipient(s) to comply with all applicable laws, rules, regulations and industry codes related to clinical and/or non-clinical research. Investigator Initiated Study Recipient(s) may be required by law to file an IND for the Study. Investigator Initiated Study Recipients are solely responsible for compliance with all applicable laws, rules, regulations and industry codes, including for example, making the IND determination and filing for the IND.
For those Studies that require IRB/IACUC approval and/or an IND, Investigator Initiated Study Recipient(s) must submit a copy of the approved IRB/IACUC and/or IND via the Acadia IIS online portal prior to study kickoff.
Clinical Trial Registration
Investigator Initiated Study Recipient(s) are required to comply with all applicable laws, rules, regulations and industry codes governing registration of protocols and posting of results such as on FDA's ClinicalTrials.gov database or another trial registry website. Investigator Initiated Study Recipient(s) should be identified as the "sponsor" on such registrations and postings, not Acadia.
Non Acadia Study Drug
Acadia shall not support the drug cost of the standard of care and it is the responsibility of the Investigator Initiated Study Recipient to maintain the Study Drug and supplies in the appropriate storage and handling conditions and to account for all Study Drug and supplies, including its receipt, usage, destruction or return.
Adverse Event Reporting
Investigator Initiated Study Recipient(s) are responsible for complying with all applicable laws, rules, regulations and industry codes concerning adverse event reporting. The Investigator Initiated Study Protocol approval notifier will include information on how to submit an adverse event to Acadia. This information is also included within the IIS Agreement.
In order to ensure the appropriate progress of research, Acadia requires that Investigator Initiated Study Recipient(s) submit an update on the study on a quarterly basis. These quarterly status reports must be submitted via the IIS online portal. Milestone payments will not be made if a quarterly status report has not been submitted for the most recent quarter. A final milestone payment will not be issued until the final study report and manuscript have been submitted (as applicable) in accordance with the research agreement.
Acadia expects the results of IISs to be published or presented, whether the results are positive or negative. Publications must take the form of either (1) a manuscript submitted to a peer-reviewed journal, or (2) an abstract submitted to a scientific or medical congress. All publications must be sent to Acadia in advance of submission, according to the timeframe set forth in the Investigator Initiated Study Agreement. All publications should comply with recognized ethical standards concerning publications, authorship and disclosure of funding, including without limitation the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, www.icmje.org, established by the International Committee of Medical Journal Editors.
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