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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
Effective Date: 20 March 2012
Activity Description Timing
Concept 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
Full Protocol Submission

Budget
Submit full protocol via Visiontracker, our on-line study management system.

Submit itemized budget with full protocol.(if funding is requested)
Protocol and budget submission should occur within 60 days of MISP-RC request for full protocol.
Full 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.clinicaltrial.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
Effective Date: 20 March 2012
Activity Description Timing*
Concept Submission Review concept 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 full protocol is requested. Notify Investigator (US) or submitter (non-US) within 10 days following MISP-RC Meeting.
Full Protocol Submission


Budget
Review full 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
Full Protocol Resubmission (in cases where comments in prior round were not addressed) Review full 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.




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© Merck & Co. Inc, Kenilworth, NJ USA is known as MSD outside the United States and Canada Privacy | Terms of Use