Investigator Initiated Studies Program
Activities and Expectations Checklist
Activity Investigator Timing Merck/MSD Timing
Letter of Intent Complete & Submit Letter of Intent Any time Review concept and Notify Notify Investigator within
(LOI) /Brief (LOI) Template (access ms word investigator of committee 8 days following Merck
Summary template via www.iisp.merck.com) decisions IISP Committee Meeting
Submit CV along with LOI
Full Protocol Complete & Submit Protocol Within 8 weeks of Review protocol and Within 8 days of IISP
Template (access ms word template Investigator Notify investigator of IISP committee decision
via www.iisp.merck.com) request for full committee decision
Protocol
Budget Complete & Submit Budget Submit with Review and approve budget Within 8 days of IISP
Template protocol committee decision
Study Execute IISP Study agreement Within 12 weeks Distribute and execute IISP Distribute upon approved
Agreements template (access ms word template of approved study agreement protocol and work with
via www.iisp.merck.com) protocol Investigator to execute
within 12 weeks
Regulatory Copy of FDA letter of receipt of IND Within 8 weeks of Provide cross –reference Upon approved protocol
Documents (if Copy of IRB/ERC Letter protocol approval. letter (if applicable)
required)
Clinical Trial Register clinical trials on Within 21 prior to Confirms registration with Prior to processing first
Registration www.clinicaltrial.gov enrolling patients receipt of NCT# payment and/or shipping
Provide NCT # for drug supply
www.clinicaltrial.gov
st
1st Payment Upon receipt of: Following receipt Issue of 1 payment Payment sent within 2-3
Final protocol or notification of weeks
Executed study agreement study documents
Confirmation of clinical trial
registration
IRB/ERC approval
Drug Supplies Track drug stocks, expiration dates, Shipped upon Provide drug supplies 8- 16 weeks but will vary
and store in a safe/secure location receipt of final dependant on availability
protocol, executed of stock and receipt and
study agreement confirmation of all
and IRB/ERC required documents
approval
1 of 3 Final Version: 7/7/2008
Investigator Initiated Studies Program
Activities and Expectations Checklist
Activity Investigator Timing Merck/MSD Timing
Study Executes the study in a specified Enrolls first patient
Execution timeframe as outlined in Protocol and within 8 weeks of
Study Agreement receipt of drug
Status Provide study progress reports to include: Every 4 months Provide status report template Requests for information
Updates Study Milestones achieved to capture study summary and issued at the end of
Summary of Study progress milestones each quarter
Enrollment figures to date
Drug supply needs or notice of
upcoming expiration
Interim Following achievement of study milestones Per study Acknowledgement of milestone Payment sent within 2-3
Payments agreement achievements weeks
Reporting If using a Marketed Product: Provide
Adverse Merck/MSD with copies of all SAE, that are Provide guidance or Upon request
Events possibly, probably or definitely related to the Within 2 working assistance (if required) to the
use of a Merck/MSD product days investigator in the reporting AE templates are
If using a Non-Marketed Product: Provide SAEs to Merck/MSD provided at start of each
Merck/MSD with copies of all SAEs study
regardless of the drug relationship to
Merck/MSD product
Study Submit a final report, abstract and/or Within 4-8 weeks Review draft study report, Within 4 weeks of
Results manuscript to IISP Committee of study abstract and/or manuscript and submission to journal or
Post Study results on clinical trial.gov completion provide discretionary scientific meeting
comments
Final Payment Upon receipt of: Within 4-8 weeks Acknowledgement of milestone Payment sent within 2-3
Final study report(manuscript) of study achievements weeks
Confirmation of study results on completion
www.clinicaltrials.com
Study Drug Destroy study drug on site according to local Within 4 weeks of Provides drug destruction letter Within 4 weeks of study
and institution policy and return drug study completion completion
destruction letter
Publication Communicate the study results to the Per Publication Provide assistance with Upon request
scientific community and to Merck/MSD Plan, prior to scientific meeting travel /hotel
submitting to reimbursement when
journal and/or applicable
presenting to
scientific meeting
2 of 3 Final Version: 7/7/2008
Investigator Initiated Studies Program
Activities and Expectations Checklist
3 of 3 Final Version: 7/7/2008