MCRU Protocol Initiation Meeting Checklist of Discussion Points

MCRU Protocol Initiation Meeting 

Checklist of Discussion Points 

MCRU Initiation Meeting Date: ________________ 

MCRU Protocol #: _________________ 

HUM #: ___________________ 

Protocol Title: 

Principal Investigator: ____________________________________Pager: _________ 

PI Demographics: K Awardee PTSP Scholar Awardee RO1 Recipient 

Other________________________________________________________________ 

Study Coordinator: _______________________________________Pager: _________ 

Study Team’s contact list received by MCRU 

MCRU Contact List please visit our webpage at http://www.michr.umich.edu/services/mcru 

Type of Study: Investigator Initiated Industry Initiated 

Adult 

Pediatric 

Extended Stay participant Outpatient participant MCRU 2U 

Protocol Specific Information: 

1. MCRU Site(s) where visits will occur: __________________________________________ 

2. Number of subjects__________________________________________________________ 

3. Number of visits____________________________________________________________ 

4. Length of stay______________________________________________________________ 

5. Study team member responsible for ensuring eligibility criteria met____________________ 

6. Study team member responsible for obtaining informed consent and providing it to MCRU 

staff _____________________________________________________________________ 

7. Study team member responsible for filing adverse events & protocol deviations? _________ 

__________________________________________________________________________ 

8. First participant is expected____________________________________________________ 

9. Additional protocol information: 

MCRU Scheduling procedures please visit our webpage https://mcrulogin.med.umich.edu/scheduling/login.aspx 

Study team scheduler_______________________________________________________________ 

** If enrolling participants that do not speak English, please reference http://med.umich.edu/irbmed/ict/Short/foreign.htm ** 

Investigational Drug Service: N/A 

Drug Name(s) including investigational drug(s), hydration, premedication(s), rescue medication(s), 

and additional medication(s): ________________________________________________________ 

________________________________________________________________________________ 

Urgency of medication dispensing (i.e. can scripts be sent in advance, or when participant arrives on 

the Unit): ________________________________________________________________________ 

_________________________________________________________________________________ 

_________________________________________________________________________________ 

Expectations regarding time for product preparation: ______________________________________ 

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_________________________________________________________________________________ 

Hold parameters and restricted medication(s): ___________________________________________ 

________________________________________________________________________________ 

Drug monitoring requirements: _______________________________________________________ 

Special supplies needed for drug administration (tubing, filters, etc.): _________________________ 

Drug is supplied by _____________________________ (billing) ____________________________ 

Drug handling and disposal - Protocol specific or per standard UMHS policies 

Bionutrition: N/A 

Fasting ______________________________________________________________________ 

Food – Drug Interaction _________________________________________________________ 

Dietary issues or protocol specific meals/snacks: ______________________________________ 

_________________________________________________________________________________ 

Dietary Record Analysis _________________________________________________________ 

Dexa Scan needed_______________________________________________________________ 

Items that may be delegated to the MCRU staff: 

Medication issues – (patient’s own medicine) 

Plan for coverage discussed 

1. PI or Co-I responsible for signing Protocol Specific Extended Stay Orders: ______________ 

2. PI or Co-I responsible for Weekend Coverage, On-call Coverage_______________________ 

3. PI or Co-I / MCRU RN responsible for screening H & P / Follow-up Outpatient Exams 

___________________________________________________________________________ 

4. Clinical Staff Procedures ______________________________________________________ 

5. Protocol specific equipment_____________________________________________________ 

Equipment training required? Yes – Add to staff training verification log No or N/A 

Core Lab: 

N/A 

Lab manual provided 

1. Equipment and/or supplies needed_______________________________________________ 

2. Lab specimen issues/processing/send outs_________________________________________ 

___________________________________________________________________________ 

3. CD labs _________________________Core Labs___________________________________ 

4. What coding system will be used for labs/CRFs for confidentiality? _____________________ 

___________________________________________________________________________ 

5. Will the Protocol utilize the MICHR Biorepository? Yes No 

Billing/Budget Issues: 

1. Billing Calendar in e-Research Exempt from completing a Billing Calendar 

2. Study Team Member responsible for billing _____________________________________ 

3. Study funded by ___________________________________________________________ 

MICHR Seed Funding MICHR Pilot Grant 

4. Study specific MRN (formally 7000#) , short code & project grant # provided by study team: 

7000 or MRN Account #_____________________ Short Code ____________________ 

Grant Number(s) _________________________________________________________ 

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Administrative Issues: 



Delegation of Authority Log N/A 

MCRU Delegation of Authority Log given to Study Team 

Received Copy of the Study Delegation of Authority Log 

MCRU Protocol Competency Verification Checklist signed by PI or designee 

Would this Study be considered? 

Observational Epidemiological Pilot Study 

Phase I Phase II Phase III 

Phase I-II 

Investigator Initiated Intervention 

Review MCRU process & provided the Study Team with a copy of the MCRU Amendment Form 

For publications, please list - MICHR Grant number: UL1RR024986 

Outstanding Issues that must be resolved prior to MCRU scheduling of participants: 

1) ___________________________________________________________________________ 

___________________________________________________________________________ 

2) ___________________________________________________________________________ 

___________________________________________________________________________ 

3) ___________________________________________________________________________ 

___________________________________________________________________________ 

4) ___________________________________________________________________________ 

___________________________________________________________________________ 

5) ___________________________________________________________________________ 

___________________________________________________________________________ 

6) ___________________________________________________________________________ 

___________________________________________________________________________ 

Copy of outstanding issues will be supplied to the study team for their follow-up. 

If you have questions or concerns after the meeting please feel free to contact: 

MCRU-InitiationTeam@med.umich.edu 

______________________________________ 

MCRU Staff Signature 

__________________________________ 

Date 

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MCRU Protocol Initiation Meeting Checklist of Discussion Points

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