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(1)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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 җΓᡏ၂ᡍہ঩཮኱ྗբ཰ำׇ5.4 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 ໨Ҟ኱ᚒȐচࣁᒦᒧቩࢗہ঩ȑǴ٠অׯ 5.1 ࢬำკ؁ᡯӜᆀϷ࣬ᜢЎҹǶ

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.ཥቚ5.2.5ଓᙫቩࢗൔ֋ࣁԖہૼޣीฝޣǴځቩࢗ຤

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।ቹҁϐᜪձϷᛦҬӄ೽ڙ၂ޣమൂϐᜪձǶ

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࿎ᆅ౛ϐำׇǶ

5. The procedure of monitoring new protocols was revised in item 5.4.3.

6.ཥቚ5.5.4ቩ่ࢗ݀ࣁȨӕཀᝩុ຾ՉǴගε཮຾Չਡ

ഢȩϐೀ౛ำׇǶ

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.”

20150923

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參考文件

(2)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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.অׯ5.6.2ቩ่ࢗ݀ࣁȨӕཀᝩុ຾ՉǴගε཮຾Չਡ

ഢȩीฝЬ࡭ΓӣᙟำׇǶ

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.অׯ5.6.5ǺཥቚीฝЬ࡭Γ҂ԏډҁ཮೚ёਜ߻όள

୺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.ཥቚ5.8.5চीฝ٩ཥਢଌቩਔϩᜪϷೀ౛ࢬำǶ

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.

20150923

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(3)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

ɎOther (Please specify): The First/Second IRB Committees

ހԛ

Version

।ኧ

No. Page

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

D 8 1.চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋/ΒΓᡏࣴزউ౛

ቩࢗہ঩཮ȩǶ

1. The original “Human Research Committee” was renamed “The First/Second IRB Committees.”

2.চȨଓᙫቩࢗཀـ߄ȩׯࣁȨଓᙫቩࢗൔ֋ਢҹቩࢗ

ख़ᗺݙཀ٣໨ᔠਡ߄ȩǴ٠অׯ5.1ǵ5.5.1Ƕ

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.অׯ5.1ࢬำკȨଌቩЎҹዴᇡȩǺཥቚቩࢗ຤ԏᏵǶ 3. Item 5.1 Flow Chart “Confirmation of Submission

Documents” was revised: “Review fee payment receipt” was added.

4.ཥቚ5.4.2ᒦᒧୋЬҺہ঩ᏼҺቩࢗہ঩ϐբ཰БԄǶ

4. Item 5.4.2 was added regarding the procedure of selecting the Vice Chair to be a reviewer.

5.অ҅5.6.5ቩࢗཀـ೯ޕीฝЬ࡭Γӣᙟයज़ϐᇥܴǶ

5. Item 5.6.5 was revised regarding the time limit for the PI to respond to reviewers’ comments.

6.ཥቚ5.7.2ε཮׫౻่݀ࣁȨόਡ঑ȩϐᇥܴǶ

6. Item 5.7.2 was added regarding the full board voting result of “disapproval.”

7.অ҅5.8.4ගрଓᙫቩࢗϐයज़ϷᛦҬ่ਢൔ֋ೕۓǶ

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/࡭ុቩࢗҙፎਜǴуຏᇥ

ܴǶ

8. The original Appendix 6.3 “PTMS Continuing Review Application Form” was deleted and a note was added.

20160318

2021.06.10

臺中榮民總醫院

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(4)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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،ۓቩࢗБԄϷᒦᒧቩࢗہ঩ȩϐ៾ೢ

ࣁ୺Չઝਜ(ঋҺہ঩ਔ)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 ೯ޕीฝЬ࡭ΓБԄǺႝηແҹׯࣁҗ

PTMSس಍Ծ୏஌วႝηແҹǶ

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.চ5.2.4.6ڙ၂ޣӕཀਜϷڙ၂ޣϭᒧ໨Ҟ।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.অׯ5.4.1୮ᒧہ঩ϐ៾ೢǺմନȐୋȑЬҺہ঩Ƕ

5. Responsible personnel for selecting reviewers was revised in item 5.4.1: “(Vice) Chair” was deleted.

6.অׯ 5.5.1ǺմନȨऩԖཀـǴளаќરᙄቪ(Ѻ)ቩࢗ

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.অ҅5.5.3Ǻচ၂ᡍਢ୺Չਔ໔ϼߏׯࣁȨ၂ᡍਢ୺Չ

ය໔ȩǹচ࿶ቩࢗہ঩ा؃ׯࣁȨளȩ࿶ቩࢗہ঩ा؃Ƕ 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

2021.06.10

臺中榮民總醫院

參考文件

(5)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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 ٩ଓᙫቩࢗਢҹቩࢗޑᜪࠠ୔ϩࣁ΋૓ቩ

่ࢗ݀Ϸᙁܰቩ่ࢗ݀Ǵཥቚ 5.5.4.1.b-c ௨Ε཮යᇥ

ܴǵϷཥቚ5.5.5.1.a-c ᙁܰቩࢗϷ௨Ε཮යᇥܴǶ 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.অׯ5.6.1ቩࢗཀـᙯҬीฝЬ࡭ΓБԄǺཥቚႝηᔞǶ

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 ቩ่ࢗ݀Ȩӕཀᝩុ຾ՉǴග

ε཮຾Չਡഢȩǵ5.6.3Ȩ໪ӆံкᇥܴȩᆶ5.6.4Ȩග ε཮૸ፕȩϐϣ৒Ƕ

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/၂ᡍीฝଓᙫቩࢗ೚ё

ਜਔǴऩȐୋȑЬҺہ঩ᏼҺቩࢗہ঩ץҢᇥܴǶ 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 ቚ6.10Ȩቩࢗہ঩ᒦᒧ߄ȩ٠ཥቚ5.9इᒵߥӸЎҹǶ 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.

20170709

2021.06.10

臺中榮民總醫院

參考文件

(6)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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 ᇥܴϣ৒Ȝऩࣁ PTMS ҙፎਢ߾໻ሡ΢໺

ႝηᔞԿس಍ջёǴคሡӑрરҁǹऩߚ PTMS ҙፎ ਢ߾ሡᔠߕ٠ϩးܭќ΋ҽၗ਑֨Ǵቩֹࢗԋࡕ߾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 ፁғᅽճ೽ڄЎวЎВයࣁȨ҇୯ 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 ၁ॊ཮᝼׫౻่݀ϐࡕុೀ౛ࢬ

ำǶќǴচ 5.7.2 ໩ۯፓ᏾ࣁ 5.7.5Ǵ٠অׯځϣ৒ඔ

ॊ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 5.7.6Ǻऩ׫౻่݀ࣁȨځдȩǴ܍ᒤΓ঩ஒε཮

،᝼೯ޕीฝЬ࡭ΓǴ٩ε཮ߕ஥،᝼ȐӵǺीฝኩ

጗୺ՉǵჴӦೖࢗ฻ȑᒤ౛Ƕ

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.

20181026

2021.06.10

臺中榮民總醫院

參考文件

(7)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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 คરϯଌቩբ཰ǴঅׯᆶȨਜय़ၗ਑ȩ࣬ᜢ

ϐϣ৒Ƕ

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 ୯ሞᇡ᛾ہ঩ϐࡌ᝼຾ՉቚঅǶ

1. The following modifications were made according to the recommendations of AAHRPP (Association for the Accreditation of Human Research Protection Program) reviewers.

2. ཥቚ 5.2.4.9ǺीฝЬ࡭ΓǵӅӕ/ڐӕЬ࡭ΓϷࣴز

Γ঩ϐᖏ׉၂ᡍϷᙴᏢউ౛࣬ᜢ૽ግፐำ᛾ܴቹҁǶ 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܌ගٮϐ૽ግፐำ᛾ܴό಄ӝೕۓǴ

໪ࡑံሸЎҹࡕБ຾ΕቩࢗำׇǶ

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.

20191018

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(8)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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. অׯচ5.3.3ϐ኱ဦࣁ 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 ଓᙫቩࢗൔ֋ਢҹቩࢗख़ᗺݙ

ཀ٣໨ᔠਡ߄ȩǶ

1. Document title was added: “PTMS Continuing Review Checklist.”

2. 5.2.4.9ቚуΑճ੻ፂँፐำ᛾ܴǶ

2. Added Item 5.2.4.9: Training certificates on Conflicts of Interest.

3. ཥቚ 5.2.4.10ǺPTMS س಍ϐᡉ๱ճ੻ጕ΢ҙൔ߄/ᡉ

๱଄୍ճ੻ᄤߚ଄୍ᜢ߯ҙൔᇥܴϷҙൔ߄Ƕ

3. Added Item 5.2.4.10: PTMS Statement of Significant Financial Interest/Statement of Significant Financial Interest and Other Relationships.

4. অׯ5.5.4.1΋૓ቩࢗϐቩ่ࢗ݀Ƕ

4. Revised the review decision of Full Board Review in item 5.5.4.1.

5. অׯ5.5.5.1ᙁܰቩࢗϐቩ่ࢗ݀Ƕ

5. Revised the review decision of Expedited Review in item 5.5.5.1.

20210528

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(9)

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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ɏද೯ ɍஏҹ ɍཱུᐒஏ

Ɏ

ɎUnclassified ɍɍConfidential ɍHighly Confidential

፾ҔൂՏ

Applied to

ɍӄଣ

ɍAll units in the hospital

ɎځдǴ٠ፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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. অׯ5.6.3ǵ5.7.3ǵ5.7.4ϐीฝЬ࡭Γӣᙟයज़ࣁ28

ঁВ᏿ϺǴ٠մନҙፎ৖ۯᇥܴЎӷǶ

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

ɁᆅڋЎҹόளᏰԾ༡ׯϷ଺૶ဦ٠࿣ЗቹӑǶ

ɁҁЎҹаKMس಍ࣁനཥހҁǴરҁวՉሡ࿶SOPᆅ౛ύЈਡകǴᝄ࿣ԾՉӈӑǶ

Changing, marking, or copying controlled documents without permission is prohibited.

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.

ҁЎҹς࿶៾ೢЬᆅ҅Ԅਡ঑Ǵ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅ౛ύЈ

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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

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

཮ᒤൂՏ

Processing Unit

ቩࢗཀـ

Review Comments

཮ᒤൂՏЬᆅ

Head of Processing Unit

คၠ೽ࣽ཮ቩሡ؃Ƕ

There is no need for review by other departments or divisions.

ɈፎӚ཮ᒤൂՏЬᆅඁ፥ቩࢗཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐ୘Ƕ 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.

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Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 1/20 ހԛ

Version Iހ 1.Ҟޑ

1. Purpose

ҁᆅ౛ำׇਜӧೕጄಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ჹܭ೯ၸቩ

ࢗϐीฝਢܭ຾Չය໔ϐଓᙫቩࢗբ཰Ƕ

ଓᙫቩࢗޑҞޑǴࢂӧᅱ࿎ीฝਢޑ୺Չၸำࢂց಄ӝচቩࢗ೯ၸ ϐीฝϣ৒Ǵаዴߥڙ၂ޣޑ៾ճکᅽࣸǶ

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 ଓᙫቩࢗ፾Ҕܭ܌Ԗہ঩཮ว๏୺Չ೚ёЪϝӧ୺Չਏයϣϐ

ीฝਢǴଓᙫቩࢗϐᓎ౗Ǵຎीฝϐ॥ᓀᆶڙ၂ޣёૈय़ᖏϐ ӒᓀำࡋԶۓǴҗ߃ቩޑΒՏЬቩہ঩ࡌ᝼ࡕǴ࿶ε཮૸ፕ،

᝼Ǵՠ؂ԃόёϿܭ΋ԛǶ

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 ीฝЬ࡭Γሡ٩ೕۓܭයज़ϣගрଓᙫൔ֋ଌҁଣಃ΋/ΒΓᡏ

ࣴزউ౛ቩࢗہ঩཮ቩࢗǶ

2.2 The PI should submit the continuing review report to TCVGH IRB before the due date.

3.ୖԵЎҹ

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 2/20 ހԛ

Version Iހ คǶ

3. References None.

4.Ӝຒۓက คǶ

4. Definitions None.

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Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 3/20 ހԛ

Version Iހ 5.բ཰ϣ৒

5. Procedure

5.1ଓᙫቩࢗᆅ౛ࢬำკ

5.1 Flow Chart of Continuing Review

ࢬำ Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ Relevant Documents

Yes

অ҅ࡕ௢ᙚ Approve after revision

໪ග཮૸ፕ Send to full board

ਡ঑Approve No

ଓᙫቩࢗҙፎContinuing Review Application

ଌቩЎҹዴᇡ Confirmation of

Submission

،ۓቩࢗБԄϷᒦᒧቩ

ࢗہ঩Review Category

& Selection of Reviewers

ہ঩ቩࢗReview

ीฝЬ࡭Γӣᙟ Response by PI

অ҅ࡕӆቩ Review after revision

ε཮ቩࢗ

Review

ଓᙫቩࢗ೚ёਜ໒ҥ Issuance of Certificate

इᒵߥӸ Records Retention

অ҅

Revision

όਡ঑

Disapprove

௢ᙚApprove

ीฝЬ࡭Γ Principal Investigator

ଌቩЎҹ/ࣴزीฝଓᙫቩࢗ೯ޕਜ/

ଓᙫቩࢗൔ֋࣬ᜢ߄ൂ

Submission documents/Notification of continuing review/Forms relevant to

continuing review report

܍ᒤΓ঩

Staff Members

ଌቩЎҹ/ቩࢗ຤ԏᏵ/

ਢҹࢬำ߄

Submission documents/Review fee payment receipt/Protocol Review Routing Form

୺Չઝਜ/ȐୋȑЬҺ ہ঩

Executive Secretary/(Vice) Chair

ଌቩЎҹ/ଓᙫቩࢗਢ/ቩࢗہ঩ᒦᒧ߄ Submission Documents/Continuing

review applications/

Reviewers Selection Form

ቩࢗہ঩

Reviewers

PTMSଓᙫቩࢗൔ֋ਢҹቩࢗख़ᗺݙཀ ٣໨ᔠਡ߄

PTMS Continuing Review Checklist

ीฝЬ࡭Γ Principal Investigator

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ቩࢗ

ཀـӣᙟ߄

Form of Response to IRB Reviewers’

Comments ہ঩

Reviewers

཮᝼इᒵ Meeting Minutes

܍ᒤΓ঩/୺Չઝਜ/

ȐୋȑЬҺہ঩

Staff/Executive Secretary/(Vice) Chair

ϦЎ/Γᡏࣴز/၂ᡍीฝଓᙫቩࢗ೚ё

Official Correspondence/ Certificate of Project Extension

܍ᒤΓ঩

Staff Members

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 4/20 ހԛ

Version Iހ 5.2ଓᙫቩࢗൔ֋ҙፎ

5.2 Continuing Review Application

5.2.1ीฝЬ࡭ΓྗഢଓᙫቩࢗЎҹȐᙑਢ໪ྗഢ҅ҁ1ҽϷቹӑ

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.)

5.2.2ीฝЬ࡭ΓԖೢҺ٩চቩࢗा؃ޑଓᙫቩࢗය໔Ь୏ᛦҬଓ

ᙫቩࢗൔ֋Ȑ΋ԃ΋ԛǵϤঁД΋ԛǵΟঁД΋ԛ܈ځдȑ

܈ܭ୺Չ೚ёਜډය߻ΒঁДஒ܌໪ၗ਑ଌԿہ঩཮Ǵа຾

Չଓᙫቩࢗ܈୺Չਏයϐ৖ۯբ཰Ƕ

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܍ᒤΓ঩ܭচቩࢗہ঩ा؃ޑଓᙫቩࢗය໔Ǵ܈୺ՉȨ೚ё

ਜȩډයВ߻ΒঁД೯ޕीฝЬ࡭ΓȐPTMS س಍ஒԾ୏஌

วႝηແҹȑǴፎीฝЬ࡭Γ٩ीฝ୺Չ຾ࡋǴ،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 ऩीฝёܭ୺Չ೚ёਜډයВ߻ֹԋǴ߾ीฝЬ࡭Γё

ܭीฝֹԋࡕΟঁДϣޔௗᛦҬȨ่ਢൔ֋߄ȩᆶ࣬ᜢ Ўҹၗ਑Ƕ

5.2.3.1 If the research will be completed before the Certificate

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Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

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 ऩीฝคݤܭ୺Չ೚ёਜډයВ߻ֹԋǴ߾ीฝЬ࡭Γ

໪ܭԏډҁ཮೯ޕࡕ 14 ঁπբϺϣᛦҬଓᙫቩࢗൔ֋

߄ᆶ࣬ᜢЎҹၗ਑Ƕ࿶ቩࢗ೯ၸࡕǴ٩চቩࢗہ঩ा؃

ޑଓᙫቩࢗᓎ౗Ȑ΋ԃ΋ԛǵϤঁД΋ԛǵΟঁД΋ԛ

܈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).

5.2.4ዴۓคݤܭ୺Չ೚ёਜډයВ߻ֹԋीฝϐीฝЬ࡭ΓǴᔈ

ᒤ౛৖ۯ୺Չ೚ёයज़ϐҙፎЋុǴ༤ִଓᙫቩࢗൔ֋߄Ǵ ଌہ঩཮܍ᒤΓ঩Ǵ٠ഢִ܌໪ߕҹၗ਑ӵΠǺ

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:

5.2.4.1ଓᙫቩࢗൔ֋ਡჹ߄

5.2.4.1 Continuing Review Report Checklist

5.2.4.2ଓᙫቩࢗൔ֋߄/ PTMSଓᙫ/࡭ុቩࢗҙፎਜȐҙፎΓ

ሡᛝകȑǶ

5.2.4.2 Continuing Review Report Form/PTMS Continuing Review Application Form (signed by PI)

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Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 6/20 ހԛ

Version

5.2.4.3ҁ཮୺Չ೚ёਜቹҁǶ

5.2.4.3 Photocopy of the Certificate of Approval issued by TCVGH IRB.

5.2.4.4ҁ཮অ҅ਢ೚ёਜቹҁǶ

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 ऩीฝਢࣁխନڙ၂ޣӕཀਜޑᖏ׉ၗ਑ԏ໣ਢ

ҹǴՠ΋ԃϣ٠ؒԖ଺ֹǴගрଓᙫቩࢗҙፎǴ໪ќග ٮၗ਑ԏ໣຾ࡋᇥܴȑǶ

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߾໻ሡ΢໺ႝηᔞԿس಍ջёǴคሡӑр રҁǹऩߚ PTMSҙፎਢ߾ሡᔠߕ٠Ȝϩးܭќ΋ҽၗ

਑֨ȝǹቩֹࢗԋࡕ߾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).

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Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 7/20 ހԛ

Version

5.2.4.9ीฝЬ࡭ΓǵӅӕ/ڐӕЬ࡭ΓϷࣴزΓ঩ϐᖏ׉၂ᡍϷ

ᙴᏢউ౛Ϸ ճ ੻ ፂ ँ ฻ ࣬ᜢ૽ግፐำ᛾ܴቹҁǶ

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 PTMSس಍ϐᡉ๱ճ੻ጕ΢ҙൔ߄/ᡉ๱଄୍ճ੻ᄤߚ

଄୍ᜢ߯ҙൔᇥܴϷҙൔ߄Ƕ

5.2.4.10 PTMS Statement of Significant Financial Interest/Statement of Significant Financial Interest and Other Relationships.

5.2.5ଓᙫቩࢗൔ֋܄፦ऩࣁԖہૼޣीฝǴ؂ԛҙፎሡᛦҬଓᙫ

ቩࢗൔ֋ቩࢗ຤Ǵ҂ᛦ຤ޣόڙ౛ҙፎЎҹǶ

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

5.3.1ቩࢗਔࣁ໪ڙ၂ޣᛝ࿿ӕཀਜϐ၂ᡍǴ؂΋ཥހᔈߕ΋ҽֹ

᏾ޑڙ၂ޣӕཀਜቹҁǴځдߕڙ၂ޣӕཀਜಃ1।ڙ၂ޣ

ၗૻǵᛝӜ।ϷԖڙ၂ޣϭᒧ໨Ҟ।य़ϐቹҁջёȐቹӑڙ ၂ޣӕཀਜਔǴሡाڙ၂ޣϭᒧ໨Ҟޑϣ৒೿ाቹӑȑǶڙ ၂ޣӕཀਜᕴҽኧեܭȐ֖ȑ30ҽϐीฝਢǴ໪ӄኧᛦҬڙ ၂ޣᛝ࿿ӕཀਜଌҁ཮ቩࢗǹऩڙ၂ޣӕཀਜᕴҽኧεܭ 30 ҽϐीฝਢǴ٩ڙ၂ޣమൂϐӕཀਜᛝ࿿Вය฻ຯКٯȐڙ ၂ޣᕴኧନа30ȑܜрǴа30ҽࣁज़ǶಃΒԃ໒ۈϐଓᙫ ቩࢗਢ໻ሡᛦҬཥԏਢ܈ཥᛝ࿿ϐڙ၂ޣӕཀਜಃ1।ڙ၂ ޣၗૻǵᛝӜ।Ϸڙ၂ޣϭᒧ।ቹҁǹऩࢂ҂યΕཥঁਢЪ

҂Ԗཥᛝ࿿ϐڙ၂ޣӕཀਜǴ໻ሡᛦҬӄ೽ڙ၂ޣమൂջ ёǶȜऩࣁ PTMS ҙፎਢ߾໻ሡ΢໺ႝηᔞԿس಍ջёǴค ሡӑрરҁǹऩߚ PTMSҙፎਢ߾ሡᔠߕ٠ϩးܭќ΋ҽၗ

਑֨Ǵቩֹࢗԋࡕ߾ஒϩးЎҹଏᗋǶȝ

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Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

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܍ᒤΓ঩ਡჹଌቩЎҹǴନଓᙫቩࢗൔ֋߄ѦǴᔈԖڙ၂ޣ

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܌ගٮϐ૽ግፐำ᛾ܴό಄ӝೕۓǴ໪ࡑံሸЎҹࡕБ

຾ΕቩࢗำׇǶ

5.3.3 If the training certificates provided to the Investigators do

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SOP for Continuing Review

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Version Iހ not meet the official requirements, the proper documentation shall be collected before application to the IRB Committee for review is accepted.

5.3.4ၗ਑ሸӄࡕǴ܍ᒤΓ঩ڙ౛ҙፎᒤ౛ϷጓဦǶऩࢂಃ΋ԛी

ฝଓᙫቩࢗൔ֋ਢǴ߾ӧচҁ཮ IRB ጓဦࡕу΢Ȩ-1ȩǴಃ

Βԛीฝ߾ࣁȨ-2ȩǴаԜᜪ௢Ƕ

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،ۓቩࢗБԄϷᒦᒧቩࢗہ঩

5.4 Decision on Review Category and Selection of Reviewers

5.4.1܍ᒤΓ঩ஒֹ᏾ϐଌቩЎҹଌ୺ՉઝਜǴ୮ᒧ΃܈ٿӜہ঩

ቩࢗǴہ঩ϐᒧ᏷а၀ीฝচٰॄೢ߃ቩϐہ঩ࣁᓬӃǶӵ ၶ੝ਸރݩளख़ཥ୮ᒧہ঩ቩࢗǶ

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.

5.4.2ୋЬҺہ঩ᏼҺቩࢗہ঩ਔǴځਢҹᔈҗЬҺہ঩ץҢǴϸ

ϐǴҭӕǶऩӢࡺคݤᒦᒧǴ߾௤៾୺Չઝਜ຾ՉץҢǶ 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.

5.4.3ीฝЬ࡭Γܭ၂ᡍය໔Ӣ࿶຤܈׷਑܈ځдӢનᏤठ҂໒ۈ

ԏਢǴЪคҺՖڙ၂ޣሡाຑ՗Ӽӄ܄Ǵځଓᙫቩࢗҙፎё

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Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

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Version Iހ җ୺Չઝਜ܈ȐୋȑЬҺہ঩ӕཀࡕǴள٩ՉࡹำׇӃ๏ϒ ਡวȨΓᡏࣴز/၂ᡍीฝଓᙫቩࢗ೚ёਜȩϷϦЎǴ٠ܭε

཮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.

5.4.4Ȩཥਢȩऩ࿶΋૓ቩࢗำׇǴࡕុϐᅱ࿎ᆅ౛Ȑջଓᙫቩࢗǵ

অ҅ਢǵ่ਢ…฻ȑǴҭӕࣁ΋૓ቩࢗำׇࣁϐȐ҇୯ 103 ԃ 07 Д 28Вፁғᅽճ೽ፁ೽ᙴӷಃ 1030120703ဦڄȑǶ ϸϐǴऩ࿶ᙁܰቩࢗำׇǴ߾ࡕុᅱ࿎ᆅ౛Ǵள௦Չᙁܰቩ

ࢗ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.

5.5ہ঩ቩࢗ

5.5 Review

5.5.1ہ঩ᔈ٩ྣ၂ᡍϐ୷ҁউ౛চ߾຾ՉቩࢗǴዴۓ၂ᡍϐ୺Չ

֡಄ӝᔈԖำׇᆶჹڙ၂ޣϐߥៈǶ

5.5.1 The reviewer should conduct the review according to the basic ethics principles of clinical trials and ensure that the

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SOP for Continuing Review

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Version Iހ implementation of the trial complies with required

procedures and protects the rights of the research subjects.

5.5.2ቩࢗว౜ୃᚆǵӒϷڙ၂ޣғڮӼӄ܈ځдၴϸ၂ᡍউ౛௃

׎Ǵ໪ҥջೀ౛ޣǴёፎȐୋȑЬҺہ঩є໒ᆙ࡚཮᝼ǹߚ ᆙ࡚௃ݩǴёा؃ीฝЬ࡭ΓܭΠ΋ԛε཮ਔډ൑ᇥܴǴѸ

ाਔӼ௨ჴӦೖࢗǶ

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.

5.5.3၂ᡍਢ୺Չය໔ǴऩӢ୯ϣݤೕঅ҅Զቹៜڙ၂ޣ៾੻Ǵள

࿶ቩࢗہ঩ा؃ፎीฝЬ࡭Γගрीฝঅ҅ਢǶ

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.

5.5.4٩ीฝਢϐቩࢗᜪࠠ୔ϩࣁ΋૓ቩ่ࢗ݀Ϸᙁܰቩ่ࢗ݀Ƕ

5.5.4 The review category of the protocol may be full board or expedited review.

5.5.4.1΋૓ቩࢗ

a.ऩቩ่ࢗ݀ࣁȨࡌ᝼೯ၸȩЪόሡӣᙟϐीฝǴ߾ޔௗ

௨Εന߈΋ԛε཮᝼ำਡഢǶ

b.ځہ঩ቩࢗޑ่݀ࣁȨࡌ᝼অ҅܈ගٮ຾΋؁ᇥܴȩǴ

ीฝЬ࡭Γᔈܭज़යϣӣᙟቩࢗཀـǴ܍ᒤΓ঩༼᏾ၗ

਑ࡕஒ၀ਢҹഋଌΕ཮ץҢൂϒ୺ՉઝਜǵȐୋȑЬҺ ہ঩ቩਡǴऩቩਡޑ่݀ࣁȨӕཀ௨Εന߈΋ԛޑε཮

ਡഢȩǴ߾ޔௗ௨Εന߈΋ԛε཮᝼ਡഢǶ

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Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

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Version Iހ c.ځہ঩ቩࢗޑ่݀ࣁȨࡌ᝼ό೯ၸ)ග཮૸ፕ*ȩǴीฝ

Ь࡭Γᔈܭज़යϣӣᙟቩࢗཀـǴ܍ᒤΓ঩༼᏾ၗ਑ࡕ ௨Εന߈΋ԛε཮᝼ำ૸ፕǶ

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.

5.5.5.1ᙁܰቩࢗ

a.ځہ঩ޑቩ่ࢗ݀ऩࣁȨࡌ᝼অ҅܈ගٮ຾΋؁ᇥܴȩǴ

ीฝЬ࡭Γᔈܭज़යϣӣᙟቩࢗཀـϷᔠଌ׳҅ߕҹǶ ऩቩࢗཀـຏܴȨঅ҅ࡕӆቩȩǴ܍ᒤΓ঩ӆஒीฝЬ࡭

Γϐӣᙟཀـᙯፎቩࢗہ঩ӆԛຑਡǶ

b.ځہ঩ޑቩ่ࢗ݀ऩࣁȨό಄ӝᙁܰቩࢗǴׯଌ΋૓ቩ

ࢗȩǴीฝЬ࡭Γᔈܭज़යϣӣᙟቩࢗཀـǴ܍ᒤΓ঩

༼᏾ၗ਑ࡕ௨Εന߈΋ԛε཮᝼ำ૸ፕǶ

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Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

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Version Iހ c.ځہ঩ޑቩ่ࢗ݀ऩࣁȨ೯ၸȩЪόሡीฝЬ࡭Γӣᙟ

ϐीฝǴ߾܍ᒤΓ঩ᔈӃஒ၀ਢҹഋଌ୺ՉઝਜǵȐୋȑ ЬҺہ঩ቩਡࡕਡว೚ёਜ٠ගԿε཮ଓᇡǶ

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.

5.6ीฝЬ࡭Γӣᙟ

5.6 The PI’s Response to Reviewers’ Comments

5.6.1྽ቩࢗہ঩ԖཀـਔǴ܍ᒤΓ঩ᔈᗦѐቩࢗޣۉӜǴ٠ஒཀ

ـϣ৒аႝηᔞଌҬीฝЬ࡭ΓǴፎځӣᙟǶ

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.

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SOP for Continuing Review

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Version Iހ 5.6.2.໪ӣᙟہ঩ቩࢗཀـϐਢҹǴीฝЬ࡭Γܭज़යϣӣᙟቩࢗ

ཀـࡕǴ܍ᒤΓ঩ᔈӃஒ၀ӣᙟഋଌ୺ՉઝਜǵȐୋȑЬҺ ہ঩ቩਡǴаዴᇡࢂցё௨Εന߈΋ԛ཮යਡഢ܈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.

5.6.3ቩࢗཀـ೯ޕीฝЬ࡭Γࡕሡܭ7ঁВ᏿ϺӣᙟǴऩຬၸ28

ঁВ᏿Ϻϝ҂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.

5.7ε཮ቩࢗ

5.7 IRB Board Meeting

5.7.1ہ঩ቩࢗය໔Ǵӵᚶᅪޕ௃ӕཀၸำ҂ပჴǴ܈ᇡࣁёૈӢ

Ӽӄ܄ᅪቾቹៜڙ၂ޣǴёࡌ᝼ගਢԿε཮૸ፕǴҗε཮،

᝼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.

5.7.2཮᝼׫౻่݀ࣁȨਡ঑ȩਢҹǴҗ܍ᒤΓ঩ഋଌȐୋȑЬҺ

ہ঩/୺ՉઝਜਡёࡕǴ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩࢗ

೚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

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SOP for Continuing Review

।ԛ

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Version Iހ Secretary.

5.7.3 ׫౻่݀ऩࣁȨঅ҅ࡕਡ঑ȩǴीฝЬ࡭ΓံҹȐӣᙟቩࢗ

ཀـȑϺኧࣁ 7ঁВ᏿ϺǴऩຬၸ28ঁВ᏿Ϻϝ҂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 ׫౻่݀ऩࣁȨঅ҅ࡕፄቩȩǴीฝЬ࡭Γᔈܭज़යȜᏃໆ

ܭ 7ঁВ᏿ϺϣӣᙟǴനᒨόૈຬၸ28ঁВ᏿ϺǴऩຬၸ28

ঁВ᏿Ϻ߾೵ՉᄖਢȝϣӣᙟቩࢗཀـǴ܍ᒤΓ঩༼᏾ၗ਑

ࡕ௨Εന߈΋ԛε཮᝼ำ૸ፕǴऩԖځдሡ؃Ǵ٩ε཮ϐ،

᝼ᒤ౛Ƕ

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 ऩࢂ׫౻่݀ࣁȨόਡ঑ȩǴ܍ᒤΓ঩ஒε཮،᝼೯ޕीฝ

Ь࡭ΓǴीฝЬ࡭Γόளᝩុ຾ՉҁࣴزǴीฝѸ໪ಖЗ܈

่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 ऩ׫౻่݀ࣁȨځдȩǴ܍ᒤΓ঩ஒε཮،᝼೯ޕीฝЬ࡭

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(26)

Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

SOP for Continuing Review

।ԛ

Page 16/20 ހԛ

Version Iހ ΓǴ٩ε཮ߕ஥،᝼ȐӵǺीฝኩ጗୺ՉǵჴӦೖࢗ฻ȑᒤ

౛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/၂ᡍीฝଓᙫቩࢗ೚ёਜ໒ҥ

5.8 Issuance of the Certificate of Project Extension

5.8.1࿶ہ঩ቩࢗӕཀ/ε཮ਡഢϐଓᙫቩࢗਢǴഋଌȐୋȑЬҺہ

঩ᙟਡӕཀࡕǴջ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩࢗ೚ё 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܍ᒤΓ঩໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩࢗ೚ёਜȩǴև

ЬҺہ঩ᛝകࡕǴаϦЎБԄวϒीฝЬ࡭ΓߥӸǶ 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.

5.8.3ፎीฝЬ࡭Γ٩Ᏽೕۓӧीฝډය߻ගрଓᙫቩࢗҙፎǴջ

٬ӧѨਏനࡕ΋ϺҙፎǴѝࢂӢࣁቩࢗਔ໔ǴԶԖޜืයޑ

ౢғǴઝਜೀϝڙ౛ೀ౛Ǵ٠ܭቩࢗӕཀࡕǴаሒௗϐ߻ӕ ཀڄਡ঑ޑВය໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩࢗ೚ё ਜȩǴό཮೷ԋԖύᘐ୺ՉਏයౢғǶ

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

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參考文件

(27)

Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

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.

5.8.4ीฝЬ࡭Γᔈܭ೚ёਜډය߻ගрଓᙫቩࢗҙፎǴऩ҂ගр

ҙፎޣᔈܭ೚ёਜډයࡕΟঁДϣᛦҬȨ่ਢൔ֋ȩǴऩ೚

ёਜԖਏයज़ၸයϤঁДࡕǴϝ҂ଌ่ਢൔ֋ϒҁ཮ቩࢗϐ

ीฝЬ࡭ΓǴኩόڙ౛ཥਢቩࢗǴߩځ่ਢൔ֋ᛦҬࡕǴۈ ڙ౛ཥਢቩࢗǶ

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 ऩচीฝܭཥਢଌቩਔࣁȬ΋૓ቩࢗȭǴ߾܍ᒤΓ঩༼᏾ၗ

਑٠௨Εന߈΋ԛε཮᝼ำǴ཮ࡕӆ໒ҥȨΓᡏࣴز/၂ᡍी

ฝଓᙫቩࢗ೚ёਜȩǹऩচीฝܭཥਢଌቩਔࣁȬᙁܰቩ

ࢗȭǴ߾ёӃ໒ҥȨΓᡏࣴز/၂ᡍीฝଓᙫቩࢗ೚ёਜȩࡕ ܭε཮຾ՉଓᇡࡕਡഢǶ

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/၂ᡍीฝଓᙫቩࢗ೚ёਜȩਔǴऩୋЬ

Һہ঩ᏼҺቩࢗہ঩ਔǴځਢҹᔈҗЬҺہ঩ץҢǴϸ

2021.06.10

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參考文件

(28)

Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2011 IRB -Regulations of Operation-2011

Ўҹ Ӝᆀ

Title

ଓᙫቩࢗᆅ౛ำׇਜ

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

࣬ᜢΓ঩ᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚ໨इᒵǶ

Relevant personnel should keep all records carefully following the guidelines below.

ጓဦ Number

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period 1 ࣴزीฝଓᙫቩࢗ೯ޕਜ

Notification of Continuing Review

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after the

trial is closed 2

ଓᙫቩࢗൔ֋ਡჹ߄

Continuing Review Report Checklist

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after the

trial is closed

3

ଓᙫቩࢗൔ֋߄/ PTMSଓᙫ/࡭ុ

ቩࢗҙፎਜ

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

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