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2"of"2"
PROVIDE"A"DESCRIPTION"OF:"
(a) Any"withdrawal(s)"of"participants"from"the"research.""Give"the"reason(s)"the"participants"withdrew:"
(b) Any"complaint(s)"about"the"research:"
HAVE"YOU"MADE"MODIFICATIONS"TO"THE"PROTOCOL"THAT"AFFECT"THE"PARTICIPANTS?" Yes" No"
If"Yes,"have"the"modifications"been"approved"by"the"IRB?"""" Yes"""" No
NOTE:((Provide(copies(of(all(cover(memos(from(all(amendments(approved(by(the(IRB(during(the (re ne wal(period .(
LIST"ANY"CHANGES"TO"THE"PROTOCO L"BEING"REQU ESTED"AT"THIS"TIME: "
WHAT"ARE"YOUR"PLANS"FOR"FUTURE"PARTICIPANT"ENROLLMENT?"
Open"to"Accrual?""""""" Yes"""" No"
If"Yes,"give"narrative"fo r "p la n s"fo r "fu tu r e "en r o llment:
If"
No,"date"closed"to"Accrual:
""
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