AmendmenttoProtocol,ICF,InvestigatorBrochure
To be used for modifications to protocol, consent, and/or Investigator Brochure
Note: if requesting a change to the informed consent due to a change in staff or research location, submit
only the “Informed Consent Revision” form.
MWMCIRBmustbenotified(inwriting)ofallproposedchangestotheprotocoland
allproposedchangestotheinformedconsentform(s).ItmustbecleartotheBoard
exactlywhatchangesarerequested,therationaleforthosechanges,andhowthe
reviseddocumentdiffersfromthedocumentthatreceivedpriorapprovalfromthe
Board
Exceptwherenecessarytoeliminateapparentimmediatehazardsto
thestudysubjects,changesmaynotbeimplementeduntilapprovedby
MWMCIRB
InstructionsforSubmission
• Therequestedchangesviaamemo,aformalamendment
document,ora“trackedchanges”versionoftheprotocol.
• Arationaleforthechanges.
• Therevisedprotocol(withnochangestracked).
• Therevisedconsentform(withchangestracked).
• Anyothermodifieditems,suchasstudyinstruments,recruitment
materials,etc.
Documentsforamendmentsshouldbesubmittedto
MWMCIRB@mwmc.com
A. Study and Amendment Information
1.
MWMCStudyNumber:
2.
NameofStudy:
3.
ProtocolNumber:
NameofPrincipalInvestigator:
NOTE:Ifyouaresubmittingonbehalfofmultipleinvestigators,pleaseprovidea
completelistingofallinvestigators.
March 2016
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AmendmenttoProtocol,ICF,InvestigatorBrochure
B. Modifications to Protocol
1.
Doesthischangeincludeaprotocolchange(i.e.,
*YES
amendment,revisedprotocol,administrativechange,etc.)? Ifyespleaseprovideifapplicable:
• AmendmentNumber___________
• DateofAmendment____________
• RevisedProtocolDate:__________
• RevisedProtocolNumber:_______
*Ifyes,submitacopyofatrackedversionoftherevised
protocoloradetailedsummaryofchanges.
NO
C. Revised Consent Information
1.
2.
Does this change include a revision to the consent?
*YES
NO
*If yes, be sure to include each revised or new document in
MS Word, with all changes tracked
List the revised Informed Consent or Assent document(s) being submitted for review,
including relevant version dates or numbers
Document Title
(New) Version date/number
D. New Informed Consent Information
List any new Informed Consent, Assent or Addendum document(s) being submitted
for review, including relevant version dates or numbers:
Document Title
March 2016
Version date/number
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AmendmenttoProtocol,ICF,InvestigatorBrochure
E. Re-consenting Information
1.
Isthisstudyopentoenrollmentofnewsubjects?
YES
NO
2.
Isthesponsorrequiringreconsenting?
YES
NO
3.
4.
Istheconsentrevisionapplicableonlytonewsubjects?
Istheconsentrevisionapplicableonlytoasub-population
oftheresearchsubjects?Ifyes,pleasespecify:
YES
YES
NO
NO
*YES
NO
F. Modifications to Investigator Brochure
1.
DoesthischangeincludearevisiontotheInvestigator
Brochure?
*Ifyes:
• IndicateVersionNumberandDate___________
Submitacopyofatrackedversionoftherevised
brochureoradetailedsummaryofchanges.
Name of Person Completing Form (contact person for questions):
Name:
Title:
PhoneNumber:
EmailAddress:
Date:
•
Signature:
PLEASE EMAIL COMPLETED FORMS AND REQUIRED DOCUMENTS TO
MWMCIRB@mwmc.com you will receive an acknowledgement once all required information has
been submitted.
INCLUDETHEFOLLOWINGWITHALLSUBMISSIONS Worddocumentwithalltrackedchangesfortheamendmentthathasbeen
submitted
RevisedProtocolwithnotrackedchanges
Rationaleforamendment
March 2016
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