Fillable Project Modification or Amendment (Samford University)

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Project Modification or Amendment (Samford University)

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Project Modification or Amendment
Federal'regulations'require'IRB'approval'before'implementing'proposed'changes.''Complete'this'form'and'attach'the'changed'
research'documents.''“Change”'means'any'change,'in'content'or'form,'to'the'protocol,'consent'form,'or'any'supportive'materials'
(such'as'the'Inves tigato r’s'Bro ch ure ,'qu estio nn aires ,'surve ys,'ad vertise m en ts,'etc.).'
Name'of'Principal'Investigator:'
Project'Title:
'Original'IRB'Approval'#:''
CURRENT'STATUS'OF'PROJECT'(check'only'one):'
Currently'in'Progress'(#'participants'entered:! )
Study'has'not'yet'begun'(no'participants'entered)'
Closed'to'participant'enrollment'(remains'active)
#'participants'on'therapy/intervention:'
#'participants'in'longterm'follow up'only:'
THIS'SUBMISSION'CHANGES'THE'STATUS'OF'THIS'STUDY'IN'THE'FOLLOWING'MANNER'(check'all'that'apply):'
Protocol'Revision'
Protocol'Amendment''
Study'Closed'to'participant'entry
Study'Terminated'
Revised'Consent'Form'
Addendum'(new)'consent'form'
Enrollment'temporarily'suspended'by'sponsor'
Other'(specify):
1. Briefly'describe,'and'explain'the'reason'for,'the'modification'or'amendment.''Include'a'copy'of'supportive'documents'with
changes'highlighte d .''Highlight'modifications/additions'to'the'consent'form,'protocol,'research'questionnaire,'etc.
2. Does'this'revision/amendment'revise'or'add'a'storage'of'samples'component?
'Yes'''' No'
3.
Does'the'change'affect'subject'participation'(e.g.'procedures,'risks,'costs,'etc.)?' Yes''' 'No
4. Does'the'change'affect'the'consent'document?
'Yes'''' 'No'
If'yes,'briefly'explain'the'changes:'
Include'the'revised'consent'form'with'the'changes'highlighted.''Will'any'participants'need'to'be'reconsented'as'a'result'of'the'
changes?'''' 'Yes'''' 'No' If'yes,'when'will'participants'be'reconsented?'
Revision/Amendment'approved'by'IRB'Committee: '''''Yes'''' 'No'
Signature'of'IRB'Chair' Date
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Project Modification or Amendment (Samford University)

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Completed 26 August 2020

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