EngageZone: Investigator Studies Program (MISP)

Investigator Studies Program (MISP): Expectations, Activities and Timelines

VERY IMPORTANT: Approval of a proposal signals our scientific agreement. Formal approval depends on mutual legal agreement, manifested by contract signature. Investigators must not initiate any work on the study before contract signature (even if scientific approval has been granted).

Investigator Responsibilities

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Activity	Description	Timing
Effective Date: 01 June 2021
Proposal Submission	Complete appropriate Investigator Studies Program-Review Committee (MISP-RC) Concept Form and submit with draft budget (if funding is requested) and date stamped Curriculum Vitae (CV) via Visiontracker, our on-line study management system.	To be decided by investigator
Protocol Submission Budget	Submit protocol via Visiontracker, our on-line study management system. Submit itemized budget with protocol.(if funding is requested)	Protocol and budget submission should occur within 60 days of MISP-RC request for full protocol.
Protocol Resubmission (in cases where comments in prior round were not addressed)	Investigator shall make the requested changes to the protocol and resubmit via Visiontracker, our on-line study management system.	Any requested revisions from MISP-RC to be incorporated and returned within 30 days
Regulatory Documents (if required)	Copy of FDA letter of receipt of Investigator New Drug Application (US Studies), if required Copy of Institutional Review Board IRB/Ethics Review Committee (ERC) Letter Registration on www.clinicaltrials.gov Date stamped CV	Within 8-12 weeks of protocol approval
Study Agreements	Execute MISP Study agreement template upon receipt from our company Do not initiate any work on the study before study agreement is signed.	Within 90 business days of approved protocol
1st Payment	Upon receipt of: Final protocol (following IRB/ERC approval) Executed study agreement Confirmation of clinical trial registration IRB/ERC approval	Following receipt or notification of study documents
Drug Supplies	Track drug stocks, expiration dates, and store in a safe/secure location	Shipped upon receipt of required regulatory documents
Status Updates	Provide study progress reports to include: Study Milestones achieved Summary of Study progress Enrollment figures to date Drug supply needs or notice of upcoming expiration	Quarterly
Reporting Adverse Events	Provide our company with copies of all of Serious Adverse Events (SAE) regardless of the drug relationship to our product Provide our company copies of all annual reports submitted to health authorities	Within 2 working days of investigator awareness
Dissemination of Data	Communicate the study results as a manuscript quality final report- to the scientific community and to our company Post the data at www.clinicaltrials.gov as a requirement for final payment	Submit to committee for review prior to submitting to journal, meeting, or public domain
Publication Follow Up	Provide our company with any additional publications, abstracts or presentations	24 months after providing our company final deliverable for final payment (Submit to committee for review prior to submitting to journal, meeting, or public domain)

MISP Responsibilities

Activity	Description	Timing*
Effective Date: 01 June 2021
Proposal Submission	Review Proposal and notify investigator of committee decision. Decisions at this point can be rejected or a full protocol requested. It is our company's responsibility to provide a rationale for rejection and comments when a protocol is requested.	Notify Investigator (US) or submitter (non-US) within 10 days following MISP-RC Meeting.
Protocol Submission Budget	Review protocol and notify investigator of committee decision. Fair Market Value Assessment performed	Notify Investigator (US) or submitter (non-US) within 10 days following MISP- RC Meeting Notify Investigator (US) or submitter (non-US) for final approved budget within 10 days following MISP-RC Meeting
Protocol Resubmission (in cases where comments in prior round were not addressed)	Review protocol and notify investigator of committee decision.	Notify Investigator (US) or submitter (non-US) within 10 days following our company's MISP-RC Meeting
Regulatory Documents (if required)	Provide cross reference letter (if applicable) for US studies	Within 2 weeks of approved protocol
Study Agreements	Distribute MISP study agreement with protocol approval letter.	Execute within 90 business days of approved protocol.
1st Payment	Issue of 1st payment	Payment sent within 4-6 weeks
Drug Supplies	Provide drug supplies	Approximately 16 weeks from approval but will vary dependant on availability of stock and receipt and confirmation of all required documents and import approvals
Status Updates	Provide status report template to capture study summary, milestones, and drug supply needs **For studies inactive for 6 months – re-evaluation between the chairman and investigator will determine the continuation of the study	Requests for information issued every 90 days after contact execution until project closed.
Reporting Adverse Events	Provide guidance or assistance (if required) to the investigator in the reporting of SAE to our company Provide our company SAE reporting language for protocol and MISP SAE fax cover form.	Upon request Adverse Event templates are provided at start of each study
Dissemination of Data	Provide manuscript template for guidance Review manuscript for courtesy review (comments don't have to be incorporated by investigator) Provide assistance with scientific meeting travel /hotel reimbursement when applicable and contingent of funding availability	Upon request
Publication Follow Up	Send status updates to investigator to capture any further publications and to follow up on the publication status of the final deliverable	Requests for information issued every 90 days until publication decision.

MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.