MCRU Protocol Initiation Meeting Checklist of Discussion Points
MCRU Protocol Initiation Meeting Checklist of Discussion Points
MCRU Protocol Initiation Meeting Checklist of Discussion Points
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<strong>MCRU</strong> <strong>Protocol</strong> <strong>Initiation</strong> <strong>Meeting</strong><br />
<strong>Checklist</strong> <strong>of</strong> <strong>Discussion</strong> <strong>Points</strong><br />
_________________________________________________________________________________<br />
Hold parameters and restricted medication(s): ___________________________________________<br />
________________________________________________________________________________<br />
Drug monitoring requirements: _______________________________________________________<br />
Special supplies needed for drug administration (tubing, filters, etc.): _________________________<br />
Drug is supplied by _____________________________ (billing) ____________________________<br />
Drug handling and disposal - <strong>Protocol</strong> specific or per standard UMHS policies<br />
Bionutrition: N/A<br />
Fasting ______________________________________________________________________<br />
Food – Drug Interaction _________________________________________________________<br />
Dietary issues or protocol specific meals/snacks: ______________________________________<br />
_________________________________________________________________________________<br />
Dietary Record Analysis _________________________________________________________<br />
Dexa Scan needed_______________________________________________________________<br />
Items that may be delegated to the <strong>MCRU</strong> staff:<br />
Medication issues – (patient’s own medicine)<br />
Plan for coverage discussed<br />
1. PI or Co-I responsible for signing <strong>Protocol</strong> Specific Extended Stay Orders: ______________<br />
2. PI or Co-I responsible for Weekend Coverage, On-call Coverage_______________________<br />
3. PI or Co-I / <strong>MCRU</strong> RN responsible for screening H & P / Follow-up Outpatient Exams<br />
___________________________________________________________________________<br />
4. Clinical Staff Procedures ______________________________________________________<br />
5. <strong>Protocol</strong> specific equipment_____________________________________________________<br />
Equipment training required? Yes – Add to staff training verification log No or N/A<br />
Core Lab:<br />
N/A<br />
Lab manual provided<br />
1. Equipment and/or supplies needed_______________________________________________<br />
2. Lab specimen issues/processing/send outs_________________________________________<br />
___________________________________________________________________________<br />
3. CD labs _________________________Core Labs___________________________________<br />
4. What coding system will be used for labs/CRFs for confidentiality? _____________________<br />
___________________________________________________________________________<br />
5. Will the <strong>Protocol</strong> utilize the MICHR Biorepository? Yes No<br />
Billing/Budget Issues:<br />
1. Billing Calendar in e-Research Exempt from completing a Billing Calendar<br />
2. Study Team Member responsible for billing _____________________________________<br />
3. Study funded by ___________________________________________________________<br />
MICHR Seed Funding MICHR Pilot Grant<br />
4. Study specific MRN (formally 7000#) , short code & project grant # provided by study team:<br />
7000 or MRN Account #_____________________ Short Code ____________________<br />
Grant Number(s) _________________________________________________________<br />
2 | P age
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