Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
A 8 ཥुǶNewly composed. 20140519 B 7 җΓᡏ၂ᡍہྗբำׇ5.4 ހᙯඤԋԜހҁǶ
This version was converted from “Version 5.4 of the Standard Operating Procedure of the Human Research Committee.”
20141125
C 8 1.অׯ 5.4 ҞᚒȐচࣁᒦᒧቩہȑǴ٠অׯ 5.1 ࢬำკᡯӜᆀϷ࣬ᜢЎҹǶ
1. The title of item 5.4 was revised (the original was “selection of reviewers”), and the procedure and relevant documents in item 5.1 Flow Chart were revised accordingly.
2.ཥቚ5.2.5ଓᙫቩൔࣁԖہૼޣीฝޣǴځቩ
ҔϐᇥܴǶ
2. Explanation about review fees was added in item 5.2.5 regarding continuing reports of contracted research projects.
3.অׯ 5.3.1 ሡᛦҬཥԏਢϐڙ၂ޣӕཀਜᛝӜ।Ϸڙ၂ޣ
ϭᒧ।ቹҁϐᜪձϷᛦҬӄڙ၂ޣమൂϐᜪձǶ
3. The following was revised in item 5.3.1: The categories of (1) requiring only photocopies of the pages of ICF with subjects’
signatures and the pages with checklists for the subjects to fill out, and (2) requiring the complete list of subjects.
4.অׯ 5.4.2 ёӃ๏ϒਡวȨΓᡏࣴز/၂ᡍीฝଓᙫቩ
ёਜȩϐచҹǶ
4. The following was revised in item 5.4.2: The criteria for issuing the Certificate of Project Extension.
5.অׯ5.4.3Ȩཥਢȩᅱ࿎ᆅϐำׇǶ
5. The procedure of monitoring new protocols was revised in item 5.4.3.
6.ཥቚ5.5.4ቩ่݀ࣁȨӕཀᝩុՉǴගεՉਡ
ഢȩϐೀำׇǶ
6. Item 5.5.4 was added regarding the follow-up procedure of the review result of “project extension approved and sent to the full board for confirmation.”
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
C 8 7.অׯ5.6.2ቩ่݀ࣁȨӕཀᝩុՉǴගεՉਡ
ഢȩीฝЬΓӣᙟำׇǶ
7. Item 5.6.2 was revised regarding the follow-up procedure of the PI's response if the review result is
“project extension approved and sent to the full board for confirmation.”
8.অׯ5.6.5ǺཥቚीฝЬΓ҂ԏډҁёਜόள
ՉीฝϐᇥܴǶ
8. The following was added to item 5.6.5: The PI must not implement the research before receiving the Certificate of Project Extension from TCVGH IRB.
9.ཥቚ5.8.5চीฝ٩ཥਢଌቩਔϩᜪϷೀࢬำǶ
9. Item 5.8.5 was added regarding the procedure of determining the review process based on the review category of the initial review of the protocol.
10.অׯߕҹ 6.9 ߄ൂӜᆀȐচΓᡏ၂ᡍࣴزीฝଓᙫቩ
ёਜȑǴ٠অׯ5.9इᒵߥӸӜᆀǶ
10. The wording of the title of Appendix 6.9 was revised (the original title being “Certificate of Clinical Trial Project Extension”), and the title of the document in item 5.9 Records Retention was revised accordingly.
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
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D 8 1.চȨΓᡏ၂ᡍہȩ׳ӜࣁȨಃ/ΒΓᡏࣴزউ
ቩہȩǶ
1. The original “Human Research Committee” was renamed “The First/Second IRB Committees.”
2.চȨଓᙫቩཀـ߄ȩׯࣁȨଓᙫቩൔਢҹቩ
ख़ᗺݙཀ٣ᔠਡ߄ȩǴ٠অׯ5.1ǵ5.5.1Ƕ
2. The original “Reviewers’ Comments Form for Continuing Review” was replaced by “IRB Continuing Review Checklist, and Appendixes 5.1, 5.5.1 were revised.
3.অׯ5.1ࢬำკȨଌቩЎҹዴᇡȩǺཥቚቩԏᏵǶ 3. Item 5.1 Flow Chart “Confirmation of Submission
Documents” was revised: “Review fee payment receipt” was added.
4.ཥቚ5.4.2ᒦᒧୋЬҺہᏼҺቩہϐբБԄǶ
4. Item 5.4.2 was added regarding the procedure of selecting the Vice Chair to be a reviewer.
5.অ҅5.6.5ቩཀـ೯ޕीฝЬΓӣᙟයज़ϐᇥܴǶ
5. Item 5.6.5 was revised regarding the time limit for the PI to respond to reviewers’ comments.
6.ཥቚ5.7.2ε౻่݀ࣁȨόਡȩϐᇥܴǶ
6. Item 5.7.2 was added regarding the full board voting result of “disapproval.”
7.অ҅5.8.4ගрଓᙫቩϐයज़ϷᛦҬ่ਢൔೕۓǶ
7. Item 5.8.4 was revised regarding the time limit for submitting continuing review applications and guideline for submitting closing reports.
8.մନচߕҹ6.3 PTMS ଓᙫ/ុቩҙፎਜǴуຏᇥ
ܴǶ
8. The original Appendix 6.3 “PTMS Continuing Review Application Form” was deleted and a note was added.
20160318
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
E 9 1.অׯࢬำკȨ،ۓቩБԄϷᒦᒧቩہȩϐೢ
ࣁՉઝਜ(ঋҺہਔ)Ƕ
1. The responsible personnel for “determination of review category and selection of reviewers” was revised in the Flow Chart:
Executive Secretary (as Reviewer).
2.অׯ5.2.1Ǻቚӈ PTMSҙፎਢྗഢЎҹᇥܴǶ
2. Item 5.2.1 was revised: Details about required documents for PTMS applications were added.
3.অׯ 5.2.3 ೯ޕीฝЬΓБԄǺႝηແҹׯࣁҗ
PTMSسԾวႝηແҹǶ
3. Item 5.2.3 was revised regarding the way of notifying the PI: “Via E-mail” was replaced by “Automatic E-mail notifications will be sent out from PTMS.”
4.চ5.2.4.6ڙ၂ޣӕཀਜϷڙ၂ޣϭᒧҞ।य़ቹҁ౽
Կ5.2.4.8Ǵ٠ቚӈPTMS ҙፎਢϷߚPTMSҙፎਢᔠ ߕЎҹᇥܴǶ
4. The original item 5.2.4.6 was changed into 5.2.4.8 regarding photocopies of ICF pages containing checklists for the subjects to fill out. Details about required documents for PTMS and non-PTMS applications were added.
5.অׯ5.4.1୮ᒧہϐೢǺմନȐୋȑЬҺہǶ
5. Responsible personnel for selecting reviewers was revised in item 5.4.1: “(Vice) Chair” was deleted.
6.অׯ 5.5.1ǺմନȨऩԖཀـǴளаќરᙄቪ(Ѻ)ቩ
ཀـȩϐӷѡǶ
6. The following sentence was deleted from item 5.5.1:
Further review comments (if any) may be written on a separate piece of paper.
7.অ҅5.5.3Ǻচ၂ᡍਢՉਔ໔ϼߏׯࣁȨ၂ᡍਢՉ
ය໔ȩǹচቩہाׯࣁȨளȩቩہाǶ 7. Item 5.5.3 was revised: “The duration of the trial was too long” was replaced by “the duration of the trial;” the original
“by request of the reviewer” was replaced by “may be requested by the reviewer.”
20170709
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
E 9 8.অׯ 5.5.4 ٩ଓᙫቩਢҹቩޑᜪࠠϩࣁቩ
่݀Ϸᙁܰቩ่݀Ǵཥቚ 5.5.4.1.b-c ௨Εයᇥ
ܴǵϷཥቚ5.5.5.1.a-c ᙁܰቩϷ௨ΕයᇥܴǶ 8. Item 5.5.4 was revised: Continuing review may be
conducted by full board review process or by expedited review process. Items 5.5.4.1 b-c were added regarding the details about placing the applications on the agenda for IRB meetings. Items 5.5.5.1 a-c were added regarding the expedited review process and details about placing the applications on the agenda for IRB meetings.
9.অׯ5.6.1ቩཀـᙯҬीฝЬΓБԄǺཥቚႝηᔞǶ
9. The way of notifying the PI of the reviewers’ comments was revised in item 5.6.1: “Electronic file” was added.
10.մନচ 5.6.2ǵ5.6.2.1 ቩ่݀ȨӕཀᝩុՉǴග
εՉਡഢȩǵ5.6.3Ȩӆံкᇥܴȩᆶ5.6.4Ȩග εፕȩϐϣǶ
10. The following phrases were deleted: “Project extension approved and sent to the full board for confirmation” from the original item 5.6.2 and item 5.6.2.1; “additional explanation required” from item 5.6.3; and “sent to the full board for discussion” from item 5.6.4.
11.ཥቚ 5.8.5.1 ܭ໒ҥΓᡏࣴز/၂ᡍीฝଓᙫቩё
ਜਔǴऩȐୋȑЬҺہᏼҺቩہץҢᇥܴǶ 11. Item 5.8.5.1 was added regarding the issuance of
the Certificate of Project Extension approved by the (Vice) Chair serving as a reviewer.
12.অׯܜඤߕҹ 6.2ǵ6.3ǵ6.6ǵ6.7ǵ6.8ǵ6.9ǵϷཥ ቚ6.10Ȩቩہᒦᒧ߄ȩ٠ཥቚ5.9इᒵߥӸЎҹǶ 12. Appendices 6.2, 6.3, 6.6, 6.7, 6.8, and 6.9 were
replaced. Appendix 6.10 “Reviewers Selection Form”
was added. Item 5.9 “Records Retention” was added.
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
F 9 1.ቚу 5.3.1 ᇥܴϣȜऩࣁ PTMS ҙፎਢ߾ሡ
ႝηᔞԿسջёǴคሡӑрરҁǹऩߚ PTMS ҙፎ ਢ߾ሡᔠߕ٠ϩးܭќҽၗ֨Ǵቩֹԋࡕ߾ஒ ϩးЎҹଏᗋǶȝ
1. The following was added to item 5.3.1: For PTMS applications, only electronic files are required to be submitted by uploading to the system. There is no need to print out paper copies. For non-PTMS applications, hard copies of submission documents should be included in a separate binder. The binder will be returned to the PI after the review is completed.
2.ቚу 5.4.4 ፁғᅽճڄЎวЎВයࣁȨ҇୯ 103 ԃ
07 Д28ВȩǶ
2. The issue date of the letter from the Ministry of Health and Welfare “28 July 2014” was added in item 5.4.4.
3.ཥቚ 5.7.2 ~ 5.7.4 ၁ॊ౻่݀ϐࡕុೀࢬ
ำǶќǴচ 5.7.2 ۯፓࣁ 5.7.5Ǵ٠অׯځϣඔ
ॊǶ
3. Item 5.7.2 ~ item 5.7.4 were added detailing the follow-up procedures on the voting results. In addition, the original item 5.7.2 changed to item 5.7.5, and its contents modified accordingly.
4.ཥቚ 5.7.6Ǻऩ౻่݀ࣁȨځдȩǴ܍ᒤΓஒε
،೯ޕीฝЬΓǴ٩εߕ،ȐӵǺीฝኩ
ՉǵჴӦೖȑᒤǶ
4. Item 5.7.6 was added: If the voting result is “other,”
then the staff member should notify the PI of the resolution. The follow-up procedure should comply with the resolution of the board meeting (e.g.
Protocol suspension, or on-site monitoring visit).
5.ܜඤߕҹ6.1ǵ6.8Ƕ
5. Appendices 6.1 and 6.8 were replaced.
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
G 20 1. ӢᔈIRB คરϯଌቩբǴঅׯᆶȨਜय़ၗȩ࣬ᜢ
ϐϣǶ
1. Process related to hardcopies was revised to comply with the new IRB policy of paperless submission.
2. ቚу5.3.1ЎѡǺڙ၂ޣӕཀਜಃ 1।ڙ၂ޣၗૻǶ
2. Item 5.7.6 was added the Informed Consent Form Page1: subject information.
3. অׯߕҹ 6.5߄ൂӜᆀǶ
3. The wording of the title of Appendix 6.5 was revised
20190527
H 21 1. ٩ᏵAAHRPP ୯ሞᇡہϐࡌՉቚঅǶ
1. The following modifications were made according to the recommendations of AAHRPP (Association for the Accreditation of Human Research Protection Program) reviewers.
2. ཥቚ 5.2.4.9ǺीฝЬΓǵӅӕ/ڐӕЬΓϷࣴز
Γϐᖏ၂ᡍϷᙴᏢউ࣬ᜢ૽ግፐำܴቹҁǶ 2. Added Item 5.2.4.9: Copies of training certificates
on clinical trials and medical ethics received by PI, CO-I, Sub-I and research members.
3. ཥቚ5.3.3Ǻऩࢂ܌ගٮϐ૽ግፐำܴό಄ӝೕۓǴ
ࡑံሸЎҹࡕБΕቩำׇǶ
3. Added Item 5.3.3: If the training certificates provided to the Investigators do not meet the official requirements, the proper documentation shall be collected before application to the IRB Committee for review is accepted.
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Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
H 21 4. অׯচ5.3.3ϐဦࣁ 5.3.4Ƕ
4. The original item number 5.3.3 was changed to 5.3.4.
5. ܜඤߕҹ 6.1ǵ6.2Ƕ
6. Appendices 6.1 and 6.2 were replaced.
20191018
I 20 1. ཥቚ߄ൂӜᆀǺȨPTMS ଓᙫቩൔਢҹቩख़ᗺݙ
ཀ٣ᔠਡ߄ȩǶ
1. Document title was added: “PTMS Continuing Review Checklist.”
2. 5.2.4.9ቚуΑճፂँፐำܴǶ
2. Added Item 5.2.4.9: Training certificates on Conflicts of Interest.
3. ཥቚ 5.2.4.10ǺPTMS سϐᡉճጕҙൔ߄/ᡉ
୍ճᄤߚ୍ᜢ߯ҙൔᇥܴϷҙൔ߄Ƕ
3. Added Item 5.2.4.10: PTMS Statement of Significant Financial Interest/Statement of Significant Financial Interest and Other Relationships.
4. অׯ5.5.4.1ቩϐቩ่݀Ƕ
4. Revised the review decision of Full Board Review in item 5.5.4.1.
5. অׯ5.5.5.1ᙁܰቩϐቩ่݀Ƕ
5. Revised the review decision of Expedited Review in item 5.5.5.1.
20210528
2021.06.10
臺中榮民總醫院
參考文件
Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l
ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄
Record of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ɏද೯ ɍஏҹ ɍཱུᐒஏ
Ɏ
ɎUnclassified ɍɍConfidential ɍHighly Confidential
ҔൂՏ
Applied to
ɍӄଣ
ɍAll units in the hospital
ɎځдǴ٠ፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
ɎOther (Please specify): The First/Second IRB Committees
ހԛ
Version
।ኧ
No. Page
Ўҹঅुᄔा
Summary of Revisions of the Document
ჴࡼВය
Date of Implementation
I 20 6. অׯ5.6.3ǵ5.7.3ǵ5.7.4ϐीฝЬΓӣᙟයज़ࣁ28
ঁВϺǴ٠մନҙፎۯᇥܴЎӷǶ
6. Item 5.6.3, 5.7.3 and 5.7.4 were revised the PI's reply period to 28 calendar days, and deleted the description of the extension.
7. ܜඤߕҹ6.2ǵ6.4ǵ6.7ǵ6.9ǵ6.10Ƕ
7. Appendices 6.2, 6.4, 6.7, 6.9 and 6.10 were replaced.
20210528
ुঅቲ
Composed/Revised/Deleted
ቩਡ
Reviewed
ਡ
Approved
ɁᆅڋЎҹόளᏰԾ༡ׯϷဦ٠ЗቹӑǶ
ɁҁЎҹаKMسࣁനཥހҁǴરҁวՉሡSOPᆅύЈਡകǴᝄԾՉӈӑǶ
䈜Changing, marking, or copying controlled documents without permission is prohibited.
䈜
䈜The latest version of this document in the Knowledge Management System (KMS) takes precedence. Distribution of hard copies of this document must be approved and stamped by the SOP Administrative Center. Copying without permission is strictly prohibited.
ҁЎҹςೢЬᆅ҅ԄਡǴ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅύЈ
2021.06.10
臺中榮民總醫院
參考文件
Ta i c h u n g Ve t e r a n s G e n e r a l H o s p i ta l
ᆅ ڋ Ў ҹ ु অ ቲ ቩ ൂ
Review Form of Composition and Revisions of Controlled Documents
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011
IRB-Regulations of Operation-2011
ЎҹӜᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
ᒤൂՏ
Processing Unit
ቩཀـ
Review Comments
ᒤൂՏЬᆅ
Head of Processing Unit
คၠࣽቩሡǶ
There is no need for review by other departments or divisions.
ɈፎӚᒤൂՏЬᆅඁ፥ቩཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐǶ ɈThe head of each processing unit is advised to provide comments before signing/stamping to approve. If needed, it is recommended that the head of each processing unit discuss with the unit that made the SOP.
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 1/20 ހԛ
Version Iހ 1.Ҟޑ
1. Purpose
ҁᆅำׇਜӧೕጄಃ/ΒΓᡏࣴزউቩہჹܭ೯ၸቩ
ϐीฝਢܭՉය໔ϐଓᙫቩբǶ
ଓᙫቩޑҞޑǴࢂӧᅱ࿎ीฝਢޑՉၸำࢂց಄ӝচቩ೯ၸ ϐीฝϣǴаዴߥڙ၂ޣޑճکᅽࣸǶ
The purpose of this SOP is to manage IRB continuing review of approved protocols. The purpose of continuing review is to monitor the implementation of the research to ensure that the procedure complies with the protocol approved by the IRB and to ensure the rights and welfare of the research subjects.
2.Ҕጄൎ 2. Scope
2.1 ଓᙫቩҔܭ܌Ԗہว๏ՉёЪϝӧՉਏයϣϐ
ीฝਢǴଓᙫቩϐᓎǴຎीฝϐ॥ᓀᆶڙ၂ޣёૈय़ᖏϐ ӒᓀำࡋԶۓǴҗ߃ቩޑΒՏЬቩہࡌࡕǴεፕ،
ǴՠԃόёϿܭԛǶ
2.1 The scope of continuing review applies to all IRB approved protocols within the validity period specified on the Certificate of Approval. The continuing review frequency is decided based on the level of risk that the study presents to the subjects. The two initial reviewers should propose the continuing review frequency to the full board for discussion and resolution. Continuing review frequency should be at least once per year.
2.2 ीฝЬΓሡ٩ೕۓܭයज़ϣගрଓᙫൔଌҁଣಃ/ΒΓᡏ
ࣴزউቩہቩǶ
2.2 The PI should submit the continuing review report to TCVGH IRB before the due date.
3.ୖԵЎҹ
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 2/20 ހԛ
Version Iހ คǶ
3. References None.
4.Ӝຒۓက คǶ
4. Definitions None.
2021.06.10
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參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 3/20 ހԛ
Version Iހ 5.բϣ
5. Procedure
5.1ଓᙫቩᆅࢬำკ
5.1 Flow Chart of Continuing Review
ࢬำ Flow Chart
ೢ
Responsible Personnel
࣬ᜢЎҹ Relevant Documents
Yes
অ҅ࡕᙚ Approve after revision
ගፕ Send to full board
ਡApprove No
ଓᙫቩҙፎContinuing Review Application
ଌቩЎҹዴᇡ Confirmation of
Submission
،ۓቩБԄϷᒦᒧቩ
ہReview Category
& Selection of Reviewers
ہቩReview
ीฝЬΓӣᙟ Response by PI
অ҅ࡕӆቩ Review after revision
εቩ
Review
ଓᙫቩёਜ໒ҥ Issuance of Certificate
इᒵߥӸ Records Retention
অ҅
Revision
όਡ
Disapprove
ᙚApprove
ीฝЬΓ Principal Investigator
ଌቩЎҹ/ࣴزीฝଓᙫቩ೯ޕਜ/
ଓᙫቩൔ࣬ᜢ߄ൂ
Submission documents/Notification of continuing review/Forms relevant to
continuing review report
܍ᒤΓ
Staff Members
ଌቩЎҹ/ቩԏᏵ/
ਢҹࢬำ߄
Submission documents/Review fee payment receipt/Protocol Review Routing Form
Չઝਜ/ȐୋȑЬҺ ہ
Executive Secretary/(Vice) Chair
ଌቩЎҹ/ଓᙫቩਢ/ቩہᒦᒧ߄ Submission Documents/Continuing
review applications/
Reviewers Selection Form
ቩہ
Reviewers
PTMSଓᙫቩൔਢҹቩख़ᗺݙཀ ٣ᔠਡ߄
PTMS Continuing Review Checklist
ीฝЬΓ Principal Investigator
ಃ/ΒΓᡏࣴزউቩہቩ
ཀـӣᙟ߄
Form of Response to IRB Reviewers’
Comments ہ
Reviewers
इᒵ Meeting Minutes
܍ᒤΓ/Չઝਜ/
ȐୋȑЬҺہ
Staff/Executive Secretary/(Vice) Chair
ϦЎ/Γᡏࣴز/၂ᡍीฝଓᙫቩё ਜ
Official Correspondence/ Certificate of Project Extension
܍ᒤΓ
Staff Members
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 4/20 ހԛ
Version Iހ 5.2ଓᙫቩൔҙፎ
5.2 Continuing Review Application
5.2.1ीฝЬΓྗഢଓᙫቩЎҹȐᙑਢྗഢ҅ҁ1ҽϷቹӑ
ҁ 1ҽǴӅ 2ҽȑǶ
5.2.1 The PI should submit the continuing review application documents. (If the protocol was previously approved, submit one original copy and one photocopy.)
5.2.2ीฝЬΓԖೢҺ٩চቩाޑଓᙫቩය໔ЬᛦҬଓ
ᙫቩൔȐԃԛǵϤঁДԛǵΟঁДԛ܈ځдȑ
܈ܭՉёਜډයΒঁДஒ܌ၗଌԿہǴа
Չଓᙫቩ܈ՉਏයϐۯբǶ
5.2.2 It is the responsibility of the PI to voluntarily submit a continuing review report to the IRB according to the required frequency determined in the initial IRB review (once per year, once every six months, once every three months, or other) or two months before the Certificate of Approval expires, in order for the continuing review to be conducted or for the research to be extended.
5.2.3܍ᒤΓܭচቩہाޑଓᙫቩය໔Ǵ܈ՉȨё
ਜȩډයВΒঁД೯ޕीฝЬΓȐPTMS سஒԾ
วႝηແҹȑǴፎीฝЬΓ٩ीฝՉࡋǴ،ۓଌቩ܌
ЎҹǶ
5.2.3 The staff member should notify the PI to submit required documents for continuing review according to the continuing review frequency required by the initial reviewers or two months before the Certificate of Approval expires. (An automatic email notice is sent out from the PTMS.)
5.2.3.1 ऩीฝёܭՉёਜډයВֹԋǴ߾ीฝЬΓё
ܭीฝֹԋࡕΟঁДϣޔௗᛦҬȨ่ਢൔ߄ȩᆶ࣬ᜢ ЎҹၗǶ
5.2.3.1 If the research will be completed before the Certificate
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 5/20 ހԛ
Version Iހ of Approval expires, then the PI may submit a closing report and relevant documents within three months after the research is completed without submitting a continuing review report.
5.2.3.2 ऩीฝคݤܭՉёਜډයВֹԋǴ߾ीฝЬΓ
ܭԏډҁ೯ޕࡕ 14 ঁπբϺϣᛦҬଓᙫቩൔ
߄ᆶ࣬ᜢЎҹၗǶቩ೯ၸࡕǴ٩চቩہा
ޑଓᙫቩᓎȐԃԛǵϤঁДԛǵΟঁДԛ
܈ځдȑۯߏࣴزीฝਏයǶ
5.2.3.2 If the research is not able to be completed before the Certificate of Approval expires, then the PI should submit a continuing review report and relevant
documents within 14 work days after receiving a notice from TCVGH IRB. Once the continuing review report is approved by IRB review, the research project may be extended according to the continuing review
frequency determined by the initial reviewers (once a year, once every six months, once every three months, or other).
5.2.4ዴۓคݤܭՉёਜډයВֹԋीฝϐीฝЬΓǴᔈ
ᒤۯՉёයज़ϐҙፎЋុǴ༤ִଓᙫቩൔ߄Ǵ ଌہ܍ᒤΓǴ٠ഢִ܌ߕҹၗӵΠǺ
5.2.4 If the research will not be completed before the Certificate of Approval expires, the PI should apply for project extension by filling out the continuing review report form and submitting it along with the following documents to the IRB staff:
5.2.4.1ଓᙫቩൔਡჹ߄
5.2.4.1 Continuing Review Report Checklist
5.2.4.2ଓᙫቩൔ߄/ PTMSଓᙫ/ុቩҙፎਜȐҙፎΓ
ሡᛝകȑǶ
5.2.4.2 Continuing Review Report Form/PTMS Continuing Review Application Form (signed by PI)
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 6/20 ހԛ
Version Iހ
5.2.4.3ҁՉёਜቹҁǶ
5.2.4.3 Photocopy of the Certificate of Approval issued by TCVGH IRB.
5.2.4.4ҁঅ҅ਢёਜቹҁǶ
5.2.4.4 Photocopy of the Certificate of Protocol Amendment issued by TCVGH IRB.
5.2.4.5ڙ၂ޣమൂᆶԏਢރݩඔॊ߄Ƕ
5.2.4.5 List of Subjects and Description of Enrollment.
5.2.4.6ᝄख़όؼ٣ҹ೯ൔइᒵ߄(೯ൔSUSAR)Ƕ
5.2.4.6 Serious Adverse Event Report Form (only SUSAR is reported)
5.2.4.7ځдȐ ऩीฝਢࣁխନڙ၂ޣӕཀਜޑᖏၗԏਢ
ҹǴՠԃϣ٠ؒԖֹǴගрଓᙫቩҙፎǴќග ٮၗԏࡋᇥܴȑǶ
5.2.4.7 Other (If the research involves collecting clinical data and qualifies for the waiver of informed consent, but is not completed within a year, then the PI should submit a continuing review application and a statement describing the progress of data collection.)
5.2.4.8Ȩڙ၂ޣӕཀਜȩᛝӜ।Ϸڙ၂ޣϭᒧ।ቹҁȐऩࣁ
PTMS ҙፎਢ߾ሡႝηᔞԿسջёǴคሡӑр રҁǹऩߚ PTMSҙፎਢ߾ሡᔠߕ٠Ȝϩးܭќҽၗ
֨ȝǹቩֹԋࡕ߾ஒϩးЎҹଏᗋȑǶ
5.2.4.8 Photocopies of the ICF pages with the subjects’
signatures and checklists filled out by the subjects (for PTMS applications, only electronic files are required to be submitted by uploading to the system. There is no need to print out paper copies. For non-PTMS applications, hard copies should be included in a separate binder. The binder will be returned to the PI after the review is completed).
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 7/20 ހԛ
Version Iހ
5.2.4.9ीฝЬΓǵӅӕ/ڐӕЬΓϷࣴزΓϐᖏ၂ᡍϷ
ᙴᏢউϷ ճ ፂ ँ ࣬ᜢ૽ግፐำܴቹҁǶ
5.2.4.9 Copies of training certificates on clinical trials, medical ethics and Conflicts of Interest received by PI, CO-I, Sub-I and research members.
5.2.4.10 PTMSسϐᡉճጕҙൔ߄/ᡉ୍ճᄤߚ
୍ᜢ߯ҙൔᇥܴϷҙൔ߄Ƕ
5.2.4.10 PTMS Statement of Significant Financial Interest/Statement of Significant Financial Interest and Other Relationships.
5.2.5ଓᙫቩൔ܄፦ऩࣁԖہૼޣीฝǴԛҙፎሡᛦҬଓᙫ
ቩൔቩǴ҂ᛦޣόڙҙፎЎҹǶ
5.2.5 If the protocol is a contracted study, then the review fee must be paid for each application of continuing review.
Applications will not be accepted or processed until the payment is made.
5.3ଌቩЎҹዴᇡ
5.3 Confirmation of Submission
5.3.1ቩਔࣁڙ၂ޣᛝӕཀਜϐ၂ᡍǴཥހᔈߕҽֹ
ޑڙ၂ޣӕཀਜቹҁǴځдߕڙ၂ޣӕཀਜಃ1।ڙ၂ޣ
ၗૻǵᛝӜ।ϷԖڙ၂ޣϭᒧҞ।य़ϐቹҁջёȐቹӑڙ ၂ޣӕཀਜਔǴሡाڙ၂ޣϭᒧҞޑϣाቹӑȑǶڙ ၂ޣӕཀਜᕴҽኧեܭȐ֖ȑ30ҽϐीฝਢǴӄኧᛦҬڙ ၂ޣᛝӕཀਜଌҁቩǹऩڙ၂ޣӕཀਜᕴҽኧεܭ 30 ҽϐीฝਢǴ٩ڙ၂ޣమൂϐӕཀਜᛝВයຯКٯȐڙ ၂ޣᕴኧନа30ȑܜрǴа30ҽࣁज़ǶಃΒԃ໒ۈϐଓᙫ ቩਢሡᛦҬཥԏਢ܈ཥᛝϐڙ၂ޣӕཀਜಃ1।ڙ၂ ޣၗૻǵᛝӜ।Ϸڙ၂ޣϭᒧ।ቹҁǹऩࢂ҂યΕཥঁਢЪ
҂Ԗཥᛝϐڙ၂ޣӕཀਜǴሡᛦҬӄڙ၂ޣమൂջ ёǶȜऩࣁ PTMS ҙፎਢ߾ሡႝηᔞԿسջёǴค ሡӑрરҁǹऩߚ PTMSҙፎਢ߾ሡᔠߕ٠ϩးܭќҽၗ
֨Ǵቩֹԋࡕ߾ஒϩးЎҹଏᗋǶȝ
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 8/20 ހԛ
Version Iހ 5.3.1 If the initial IRB review determined that ICF is required for
the research, then the application should include a
complete photocopy of each new version of the ICF. For the other ICFs of the same version, only photocopies of the pages with the subject’s information, signatures and
checklists need to be submitted (photocopies of all of the items for the subjects to fill out on the checklist should be submitted). If the protocol has fewer than 30 ICFs, all of the ICFs should be submitted to the IRB for review. If the protocol has more than 30 ICFs, then up to 30 ICFs should be submitted. An approximately equal number of ICFs should be selected from each date that the ICFs were signed. For continuing review applications of
second-year research, if new subjects are recruited and new ICFs are signed, submit photocopies of the pages of ICF with the subject’s information, signatures and the pages with checklists for the subjects to fill out. If no new subjects are recruited, then only a list of all subjects needs to be submitted. ˰For PTMS applications, only electronic files are required to be submitted by uploading to the
system. There is no need to print out paper copies. For non-PTMS applications, hard copies of submission
documents should be included in a separate binder. The binder will be returned to the PI after the review is
completed.ȝ
5.3.2܍ᒤΓਡჹଌቩЎҹǴନଓᙫቩൔ߄ѦǴᔈԖڙ၂ޣ
మൂǶऩ၂ᡍය໔මวғᝄख़όؼ٣ҹǴᔈߕ೯ൔइᒵǶ 5.3.2 When checking the submission documents, the staff
member should make sure that a list of subjects has been submitted along with the continuing review report form. If serious adverse events happened during the study, a record of relevant reports should also be submitted.
5.3.3ऩࢂ܌ගٮϐ૽ግፐำܴό಄ӝೕۓǴࡑံሸЎҹࡕБ
ΕቩำׇǶ
5.3.3 If the training certificates provided to the Investigators do
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 9/20 ހԛ
Version Iހ not meet the official requirements, the proper documentation shall be collected before application to the IRB Committee for review is accepted.
5.3.4ၗሸӄࡕǴ܍ᒤΓڙҙፎᒤϷጓဦǶऩࢂಃԛी
ฝଓᙫቩൔਢǴ߾ӧচҁ IRB ጓဦࡕуȨ-1ȩǴಃ
Βԛीฝ߾ࣁȨ-2ȩǴаԜᜪǶ
5.3.4 After compiling the submission documents, the staff member should give the application a number and process the application. The number given to the first continuing review report application should be “-1” followed by the original IRB number. The number given to the second continuing review report application should be “-2” followed by the original IRB number. The same rule goes with the third and the fourth, etc.
5.4،ۓቩБԄϷᒦᒧቩہ
5.4 Decision on Review Category and Selection of Reviewers
5.4.1܍ᒤΓஒֹϐଌቩЎҹଌՉઝਜǴ୮ᒧ܈ٿӜہ
ቩǴہϐᒧа၀ीฝচٰॄೢ߃ቩϐہࣁᓬӃǶӵ ၶਸރݩளख़ཥ୮ᒧہቩǶ
5.4.1 The staff member should submit the application documents to the Executive Secretary. The Executive Secretary should then assign one or two reviewers, preferably the original reviewers of the protocol. Under special circumstances, new reviewers may be assigned.
5.4.2ୋЬҺہᏼҺቩہਔǴځਢҹᔈҗЬҺہץҢǴϸ
ϐǴҭӕǶऩӢࡺคݤᒦᒧǴ߾ՉઝਜՉץҢǶ 5.4.2 If the Vice Chair serves as a reviewer, the selection of
reviewers should be approved by the Chair, and vice versa.
If the (Vice) Chair is unable to sign the approval, then the Executive Secretary will be authorized to approve the selection of reviewers.
5.4.3ीฝЬΓܭ၂ᡍය໔Ӣ܈܈ځдӢનᏤठ҂໒ۈ
ԏਢǴЪคҺՖڙ၂ޣሡाຑӼӄ܄Ǵځଓᙫቩҙፎё
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 10/20 ހԛ
Version Iހ җՉઝਜ܈ȐୋȑЬҺہӕཀࡕǴள٩ՉࡹำׇӃ๏ϒ ਡวȨΓᡏࣴز/၂ᡍीฝଓᙫቩёਜȩϷϦЎǴ٠ܭε
ଓᇡࡕਡഢǶ
5.4.3 In the case that the PI has not recruited subjects due to lack of funding, materials, or other reasons, and no
subjects have enrolled that would require any assessment of safety, the continuing review application may be
approved by the Executive Secretary or (Vice) Chair and the Certificate of Project Extension and an official letter may be issued complied with the administrative procedure.
The application and approval will then be confirmed later in an IRB board meeting.
5.4.4ȨཥਢȩऩቩำׇǴࡕុϐᅱ࿎ᆅȐջଓᙫቩǵ
অ҅ਢǵ่ਢ…ȑǴҭӕࣁቩำׇࣁϐȐ҇୯ 103 ԃ 07 Д 28Вፁғᅽճፁᙴӷಃ 1030120703ဦڄȑǶ ϸϐǴऩᙁܰቩำׇǴ߾ࡕុᅱ࿎ᆅǴள௦Չᙁܰቩ
ำׇǶ
5.4.4 If the protocol was sent to the full board for review as a new protocol, all of the follow-up monitoring (including continuing review, protocol amendment, protocol closure, etc.) should be sent to the full board for review as well (in compliance with the letter issued by the Ministry of Health and Welfare on 28 July 2014, pursuant to Wei-Bu-Yi-Zi No.
1030120703). If the protocol was reviewed by the expedited review process as a new protocol, then the follow-up monitoring should be conducted by the expedited review process.
5.5ہቩ
5.5 Review
5.5.1ہᔈ٩ྣ၂ᡍϐ୷ҁউচ߾ՉቩǴዴۓ၂ᡍϐՉ
֡಄ӝᔈԖำׇᆶჹڙ၂ޣϐߥៈǶ
5.5.1 The reviewer should conduct the review according to the basic ethics principles of clinical trials and ensure that the
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 11/20 ހԛ
Version Iހ implementation of the trial complies with required
procedures and protects the rights of the research subjects.
5.5.2ቩวୃᚆǵӒϷڙ၂ޣғڮӼӄ܈ځдၴϸ၂ᡍউ
ǴҥջೀޣǴёፎȐୋȑЬҺہє໒ᆙ࡚ǹߚ ᆙ࡚ݩǴёाीฝЬΓܭΠԛεਔډᇥܴǴѸ
ाਔӼ௨ჴӦೖǶ
5.5.2 If the reviewer discovers any protocol deviation, incident that endangers the subjects’ safety, or any other violation against trial ethics that requires immediate action, then the reviewer may ask the (Vice) Chair to call an emergency IRB meeting. If the incident is not urgent, then the PI may be required to attend the next scheduled IRB meeting to give explanation. An on-site monitoring visit may also be arranged if needed.
5.5.3၂ᡍਢՉය໔ǴऩӢ୯ϣݤೕঅ҅Զቹៜڙ၂ޣǴள
ቩہाፎीฝЬΓගрीฝঅ҅ਢǶ
5.5.3 During the trial period, if the subjects’ rights are affected due to any modification of national regulations, then the reviewer may require the PI to submit a protocol amendment application.
5.5.4٩ीฝਢϐቩᜪࠠϩࣁቩ่݀Ϸᙁܰቩ่݀Ƕ
5.5.4 The review category of the protocol may be full board or expedited review.
5.5.4.1ቩ
a.ऩቩ่݀ࣁȨࡌ೯ၸȩЪόሡӣᙟϐीฝǴ߾ޔௗ
௨Εന߈ԛεำਡഢǶ
b.ځہቩޑ่݀ࣁȨࡌঅ҅܈ගٮᇥܴȩǴ
ीฝЬΓᔈܭज़යϣӣᙟቩཀـǴ܍ᒤΓ༼ၗ
ࡕஒ၀ਢҹഋଌΕץҢൂϒՉઝਜǵȐୋȑЬҺ ہቩਡǴऩቩਡޑ่݀ࣁȨӕཀ௨Εന߈ԛޑε
ਡഢȩǴ߾ޔௗ௨Εന߈ԛεਡഢǶ
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 12/20 ހԛ
Version Iހ c.ځہቩޑ่݀ࣁȨࡌό೯ၸ)ගፕ*ȩǴीฝ
ЬΓᔈܭज़යϣӣᙟቩཀـǴ܍ᒤΓ༼ၗࡕ ௨Εന߈ԛεำፕǶ
5.5.4.1 Full Board Review
a. If the review decision is “recommended” and no response is required, then the continuing review report should be placed on the agenda for the next scheduled IRB meeting for confirmation.
b. If the review decision is “recommended for revision or provided further explanation” and response from the PI is required, then the PI should respond to the reviewers’ comments by the due date. The staff member should compile relevant documents and submit them to the Executive Secretary and the (Vice) Chair for approval. If the result is “approved to be placed on the agenda for the next scheduled IRB board meeting for confirmation,” then the application should be placed on the agenda for the next scheduled board meeting for confirmation.
c. If the review decision is “sent to the full board for discussion,” then the PI should respond to the reviewers’ comments by the due date. The staff member should compile relevant documents and place the application on the agenda for the next scheduled IRB board meeting for discussion.
5.5.5.1ᙁܰቩ
a.ځہޑቩ่݀ऩࣁȨࡌঅ҅܈ගٮᇥܴȩǴ
ीฝЬΓᔈܭज़යϣӣᙟቩཀـϷᔠଌ׳҅ߕҹǶ ऩቩཀـຏܴȨঅ҅ࡕӆቩȩǴ܍ᒤΓӆஒीฝЬ
ΓϐӣᙟཀـᙯፎቩہӆԛຑਡǶ
b.ځہޑቩ่݀ऩࣁȨό಄ӝᙁܰቩǴׯଌቩ
ȩǴीฝЬΓᔈܭज़යϣӣᙟቩཀـǴ܍ᒤΓ
༼ၗࡕ௨Εന߈ԛεำፕǶ
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 13/20 ހԛ
Version Iހ c.ځہޑቩ่݀ऩࣁȨ೯ၸȩЪόሡीฝЬΓӣᙟ
ϐीฝǴ߾܍ᒤΓᔈӃஒ၀ਢҹഋଌՉઝਜǵȐୋȑ ЬҺہቩਡࡕਡวёਜ٠ගԿεଓᇡǶ
5.5.5.1 Expedited Review
a. If the review decision is “recommended for revision or provided further explanation,” then the PI should
respond to the reviewers’ comments and submit
relevant revised documents. If the review decision is
“further review after revisions,” the response and supplementary documents from the PI should be sent to the reviewers for evaluation.
b. If the review decision is “not meet the requirements for expedited review and sent to the full board for
discussion,” then the PI should respond to the reviewers’ comments by the due date. The staff
member should compile relevant documents and place the application on the agenda for the next scheduled IRB board meeting for discussion.
c. If the review decision is “recommended for approval”
and no response from the PI is required, then the staff member should submit the application to the Executive Secretary and the (Vice) Chair for approval. Once the application is approved, a Certificate of Project
Extension should be issued, and the approval should be sent to the IRB board meeting for confirmation.
5.6ीฝЬΓӣᙟ
5.6 The PI’s Response to Reviewers’ Comments
5.6.1ቩہԖཀـਔǴ܍ᒤΓᔈᗦѐቩޣۉӜǴ٠ஒཀ
ـϣаႝηᔞଌҬीฝЬΓǴፎځӣᙟǶ
5.6.1 If the reviewer has comments, the staff member should remove the reviewer’s name before sending the comments to the PI for response. The comments should be sent in an electronic file.
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 14/20 ހԛ
Version Iހ 5.6.2.ӣᙟہቩཀـϐਢҹǴीฝЬΓܭज़යϣӣᙟቩ
ཀـࡕǴ܍ᒤΓᔈӃஒ၀ӣᙟഋଌՉઝਜǵȐୋȑЬҺ ہቩਡǴаዴᇡࢂցё௨Εന߈ԛයਡഢ܈ሡගԿε
ፕǶ
5.6.2 If the review requires the PI to submit response to reviewers’ comments, then the PI should give response by the due date. The staff member should submit the response to the Executive Secretary and the (Vice) Chair for evaluation to decide if the response should be placed on the agenda for the next scheduled IRB board meeting for discussion.
5.6.3ቩཀـ೯ޕीฝЬΓࡕሡܭ7ঁВϺӣᙟǴऩຬၸ28
ঁВϺϝ҂ӣᙟ߾ՉᄖਢǶ
5.6.3 The PI should respond to reviewers’ comments within 7 calendar days. If the PI does not respond within 28
calendar days, the protocol should be withdrawn from IRB consideration.
5.7εቩ
5.7 IRB Board Meeting
5.7.1ہቩය໔Ǵӵᚶᅪޕӕཀၸำ҂ပჴǴ܈ᇡࣁёૈӢ
Ӽӄ܄ᅪቾቹៜڙ၂ޣǴёࡌගਢԿεፕǴҗε،
Ƕ
5.7.1 During the review process, if the reviewer has concerns about the execution of informed consent or about the safety of the subjects, the reviewer may make a motion to the IRB board meeting for discussion and resolution.
5.7.2౻่݀ࣁȨਡȩਢҹǴҗ܍ᒤΓഋଌȐୋȑЬҺ
ہ/ՉઝਜਡёࡕǴ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩ
ёਜȩǶ
5.7.2 If the IRB full board voting result is “approval,” then the staff member should issue the Certificate of Project
Extension with the approval of the (Vice) Chair/Executive
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 15/20 ހԛ
Version Iހ Secretary.
5.7.3 ౻่݀ऩࣁȨঅ҅ࡕਡȩǴीฝЬΓံҹȐӣᙟቩ
ཀـȑϺኧࣁ 7ঁВϺǴऩຬၸ28ঁВϺϝ҂ӣᙟ߾
ՉᄖਢǶ
5.7.3 If the voting result is “approval after revision,” the PI should submit supplementary documents (or respond to
reviewers’ comments) within 7 calendar days. If the PI does not respond within 28 calendar days, the protocol should be withdrawn from IRB consideration.
5.7.4 ౻่݀ऩࣁȨঅ҅ࡕፄቩȩǴीฝЬΓᔈܭज़යȜᏃໆ
ܭ 7ঁВϺϣӣᙟǴനᒨόૈຬၸ28ঁВϺǴऩຬၸ28
ঁВϺ߾ՉᄖਢȝϣӣᙟቩཀـǴ܍ᒤΓ༼ၗ
ࡕ௨Εന߈ԛεำፕǴऩԖځдሡǴ٩εϐ،
ᒤǶ
5.7.4 If the voting result is “further review after revision,” the PI should respond to the reviewers’ comments before the due date. (The PI should try to respond within 7 calendar days and no later than 28 calendar days. If the PI does not respond within 28 calendar days, the protocol should be withdrawn from IRB consideration.) The staff member should compile relevant documents and place the request on the agenda for the next IRB board meeting for
discussion. Any other outstanding requests should be handled according to the resolutions made in the board meeting.
5.7.5 ऩࢂ౻่݀ࣁȨόਡȩǴ܍ᒤΓஒε،೯ޕीฝ
ЬΓǴीฝЬΓόளᝩុՉҁࣴزǴीฝѸಖЗ܈
่ਢǶ
5.7.5 If the voting result is “disapproval,” the staff member should notify the PI of the resolution. The PI may not proceed with the research. The research must be terminated or closed.
5.7.6 ऩ౻่݀ࣁȨځдȩǴ܍ᒤΓஒε،೯ޕीฝЬ
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 16/20 ހԛ
Version Iހ ΓǴ٩εߕ،ȐӵǺीฝኩՉǵჴӦೖȑᒤ
Ƕ
5.7.6 If the voting result is “other,” then the staff member should notify the PI of the resolution. The follow-up procedure should comply with the resolution of the board meeting (e.g. Protocol suspension, or on-site monitoring visit).
5.8Γᡏࣴز/၂ᡍीฝଓᙫቩёਜ໒ҥ
5.8 Issuance of the Certificate of Project Extension
5.8.1ہቩӕཀ/εਡഢϐଓᙫቩਢǴഋଌȐୋȑЬҺہ
ᙟਡӕཀࡕǴջ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩё ਜȩǶ
5.8.1 If a continuing review report application is approved by the reviewers and confirmed by the IRB board meeting, then a Certificate of Project Extension will be issued with the approval of the (Vice) Chair.
5.8.2 җ܍ᒤΓ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩёਜȩǴև
ЬҺہᛝകࡕǴаϦЎБԄวϒीฝЬΓߥӸǶ 5.8.2 The staff member should issue the Certificate of Project
Extension and submit it to the Chair for approval stamp/signature. Then the Certificate of Project Extension should be sent to the PI via official correspondence.
5.8.3ፎीฝЬΓ٩ᏵೕۓӧीฝډයගрଓᙫቩҙፎǴջ
٬ӧѨਏനࡕϺҙፎǴѝࢂӢࣁቩਔ໔ǴԶԖޜืයޑ
ౢғǴઝਜೀϝڙೀǴ٠ܭቩӕཀࡕǴаሒௗϐӕ ཀڄਡޑВය໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩё ਜȩǴόԋԖύᘐՉਏයౢғǶ
5.8.3 The PI should submit a continuing review application
according to the IRB requirements. Even if the PI submits the application on the last effective date of the Certificate of Approval, the IRB Secretariat should still accept and process the application. If the Certificate of Approval
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 17/20 ހԛ
Version Iހ expires during the review process, once the continuing
review application is approved, the start date of the Certificate of Project Extension should be expiry date of the Certificate of Approval for the continuation of the research project.
5.8.4ीฝЬΓᔈܭёਜډයගрଓᙫቩҙፎǴऩ҂ගр
ҙፎޣᔈܭёਜډයࡕΟঁДϣᛦҬȨ่ਢൔȩǴऩ
ёਜԖਏයज़ၸයϤঁДࡕǴϝ҂ଌ่ਢൔϒҁቩϐ
ीฝЬΓǴኩόڙཥਢቩǴߩځ่ਢൔᛦҬࡕǴۈ ڙཥਢቩǶ
5.8.4 The PI should submit a continuing review application before the Certificate of Approval expires. If the PI does not submit the application, then a closing report should be submitted within three months after the expiry date of the Certificate of Approval. If the PI does not submit a closing report within six months after the expiry date, then any new protocol submission application from the PI will not be accepted by the IRB until a closing report is submitted.
5.8.5 ऩচीฝܭཥਢଌቩਔࣁȬቩȭǴ߾܍ᒤΓ༼ၗ
٠௨Εന߈ԛεำǴࡕӆ໒ҥȨΓᡏࣴز/၂ᡍी
ฝଓᙫቩёਜȩǹऩচीฝܭཥਢଌቩਔࣁȬᙁܰቩ
ȭǴ߾ёӃ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩёਜȩࡕ ܭεՉଓᇡࡕਡഢǶ
5.8.5 If the protocol was initially approved by full board review, then the staff member should compile relevant documents and place the application on the agenda for the next
scheduled IRB board meeting. After the application is approved by the full board, the Certificate of Project Extension should be issued. If the protocol was initially approved by expedited review process, then the Certificate of Project Extension may be issued first and confirmed in an IRB board meeting later.
5.8.5.1໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩёਜȩਔǴऩୋЬ
ҺہᏼҺቩہਔǴځਢҹᔈҗЬҺہץҢǴϸ
2021.06.10
臺中榮民總醫院
參考文件
Taichung Veterans General Hospital
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2011 IRB -Regulations of Operation-2011
Ўҹ Ӝᆀ
Title
ଓᙫቩᆅำׇਜ
SOP for Continuing Review
।ԛ
Page 18/20 ހԛ
Version Iހ ϐǴҭӕǶ
5.8.5.1 If the Vice Chair serves as a reviewer, the Certificate of Project Extension should be signed by the Chair, and vice versa.
5.9इᒵߥӸ
5.9 Records Retention
࣬ᜢΓᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚइᒵǶ
Relevant personnel should keep all records carefully following the guidelines below.
ጓဦ Number
इᒵӜᆀ Name of Document
ߥӸӦᗺ Retention Location
ߥӸයज़ Retention Period 1 ࣴزीฝଓᙫቩ೯ޕਜ
Notification of Continuing Review
IRBᔞਢ࠻
IRB Archive
၂ᡍ่״ࡕ3ԃ At least 3 years after the
trial is closed 2
ଓᙫቩൔਡჹ߄
Continuing Review Report Checklist
IRBᔞਢ࠻
IRB Archive
၂ᡍ่״ࡕ3ԃ At least 3 years after the
trial is closed
3
ଓᙫቩൔ߄/ PTMSଓᙫ/ុ
ቩҙፎਜ
Continuing Review Report Form/PTMS Continuing Review Application Form
IRBᔞਢ࠻
IRB Archive
၂ᡍ่״ࡕ3ԃ At least 3 years after the
trial is closed
4
ڙ၂ޣమൂᆶԏਢރݩඔॊ߄ List of Subjects and Description of Enrollment
IRBᔞਢ࠻
IRB Archive
၂ᡍ่״ࡕ3ԃ At least 3 years after the
trial is closed
5
ᝄख़όؼ٣ҹ೯ൔइᒵ߄(೯ൔ SUSAR)
Serious Adverse Event Report Form (only SUSAR is reported)
IRBᔞਢ࠻
IRB Archive
၂ᡍ่״ࡕ3ԃ At least 3 years after the
trial is closed
2021.06.10
臺中榮民總醫院
參考文件