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ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

A 21 ཥुǶNewly composed. 20140519 B 6 җΓᡏ၂ᡍہ঩཮኱ྗբ཰ำׇ 5.4ހᙯඤԋԜހҁǶ

This version was converted from “Version 5.4 of the SOP of the Human Research Committee.”

20141125

C 6 1.অׯ5.2.1่ਢൔ֋ЎҹኧໆǶ

1. The number of documents for the closing report was modified in item 5.2.1.

2. ஒচ5.3.1ڙ၂ޣᛝ࿿ӕཀਜϐ၂ᡍᔠߕၗ਑ޑᇥܴ

ࢤ౽Կ 5.2.2.5Ƕ

2. The details regarding required documents for protocols that include ICFs were moved from item 5.3.1 to item 5.2.2.5.

3. ཥቚ 5.3.1܍ᒤΓ঩ਡჹଌቩЎҹϐϣЎǶ

3. Item 5.3.1 was added: The staff member should verify that the content of the submitted documents is complete.

4. অׯ 5.4.኱ᚒȐচᒦᒧቩࢗہ঩ȑϷ5.4.1ǵ5.4.2ᒦ ᒧہ঩ϐϣЎǹཥቚ 5.4.3 ཥਢቩࢗϷᅱ࿎ᆅ౛ำ

ׇǹ٠অׯ 5.1ࢬำკϐ؁ᡯϷ࣬ᜢЎҹǶ

4. The title of item 5.4 was revised (the original was

“selection of reviewers”); the content regarding selection of reviewers in items 5.4.1 and 5.4.2 were revised; the procedure and relevant documents in item 5.1 Flow Chart were revised.

5. ཥ 5.5.3ቩࢗว౜ୃᚆǵӒϷڙ၂ޣғڮӼӄ܈ځд

ၴϸ၂ᡍউ౛௃׎ϐೀ౛БԄǶ

5. Item 5.5.3 was added regarding actions taken when reviewers discover protocol deviation incidents or other incidents that affect the subjects’

safety or violate clinical research ethics.

20150923

2021.06.10

臺中榮民總醫院

參考文件

(2)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

C 6 6. অׯ5.6.2ऩቩ่ࢗ݀ࣁȨӕཀ่ਢȩޣϐೀ౛ࢬำǶ

6. Item 5.6.2 was revised regarding the follow-up procedure of the review decision of “approval of study closure.”

7. অׯߕҹ 6.8߄ൂӜᆀȐচΓᡏࣴز/၂ᡍीฝ่ਢ೯ ޕȑǴ٠অׯϣЎǶ

7. The title of the form in item 6.8 was revised (the original was “Approval of Human Research/Clinical Trial Study Closure”), and the content was revised accordingly.

20150923

D 6 1. চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋/ΒΓᡏࣴزউ

౛ቩࢗہ঩཮ȩǶ

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

2. অׯ5.2.2ǺҙፎΓᛝകׯࣁᛝӜǶ

2. Item 5.2.2 was revised: “Signature/stamp of the applicant” was replaced by “signature of the applicant.”

3. চ嘸ቩࢗཀـ߄嘹ׯࣁȨ่ਢਢҹቩࢗख़ᗺݙཀ٣໨ᔠ ਡ߄ȩǺ5.1ǵ5.5.1ǵ5.9ǵߕҹ6.4Ƕ

3. The original “Reviewers’ Comments Form” was replaced by “IRB Review Checklist for Study Closure,” and items 5.1, 5.5.1, 5.9 and Appendix 6.4 were revised accordingly.

4. অׯ5.6.2ቩ่ࢗ݀ǺচȨӕཀ่ਢȩׯࣁȨӕཀ่

ਢǴගε཮຾Չଓᇡ/ਡഢȩǶ

4. Item 5.6.2 was revised regarding review decisions:

“Study closure approved” was replaced by “study closure approved and sent to the full board for confirmation/recordation.”

20160318

2021.06.10

臺中榮民總醫院

參考文件

(3)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

D 6 5. Ўӷਠ҅Ƕ

5. Typos were fixed.

6. অ҅ 5.6.5ǺीฝЬ࡭Γӣᙟቩࢗཀـϐ࣬ᜢೕۓǶ

6. Item 5.6.5 was revised regarding the procedure for the PI to respond to reviewers’ comments.

7. ཥቚ 5.7.3ε཮׫౻่݀ࣁȨόਡ঑ȩϐ࣬ᜢೕۓǶ

7. Item 5.7.3 was added regarding the full board voting result of “disapproved.”

8. մନচߕҹ 6.2 PTMS่ਢҙፎਜǴ٠уຏᇥܴǶ 8. The original Appendix 6.2 “PTMS Study Closure

Application Form” was deleted, and a note was added.

20160318

E 7 1. অׯ5.1 ࢬำკȨ،ۓቩࢗБԄϷᒦᒧቩࢗہ঩ȩ៾

ೢǶ

1. The responsible personnel was revised regarding

“Determination of Review Category and Selection of Reviewers” in 5.1 Flow Chart.

2. ཥቚ 5.2.2.6 ڙ၂ޣӕཀਜϷڙ၂ޣϭᒧ໨Ҟႝηᔞ

܈ቹҁϐ࣬ᜢೕۓǶ

2. Item 5.2.2.6 was added regarding the requirement of submitting electronic file or photocopy of the ICFs and pages with checklists for the subjects to fill in on the ICFs.

3. ཥቚ5.2.5୺Չ೚ёਜၸයЪຬၸ3ԃ҂ᛦҬଓᙫቩ

ࢗൔ֋ਢҹϐೀ౛ᇥܴǶ

3. Item 5.2.5 was added regarding the procedure of handling a protocol for which the Certificate of Approval has expired and no continuing review report has been submitted for the last three years.

20170709

2021.06.10

臺中榮民總醫院

參考文件

(4)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

E 7 4. অׯ 5.4.1ᒦᒧቩࢗہ঩ϐ៾ೢǺմନȐୋȑЬҺہ

঩Ƕ

Item 5.4.1 was revised regarding the responsible personnel for selecting reviewers: “(Vice) Chair”

was deleted.

4. অׯ 5.5.1ǺմନऩԖཀـǴளаќરᙄቪቩࢗཀـǶ

5. The following sentence was deleted from item 5.5.1: Further review comments (if any) may be written on a separate piece of paper.

6. ཥቚ 5.5.4 ीฝਢϐቩࢗᜪࠠǵ5.5.4.1 ΋૓ቩࢗϷ

5.5.4.2 ᙁܰቩࢗϷΕ཮௨ำᇥܴǶ

6. Item 5.5.4 was added regarding the review category of the protocol; item 5.5.4.1 was added regarding full board review; item 5.5.4.2 was added regarding expedited review and procedure of placing a protocol on the agenda for the board meeting.

7. অׯཥቚ5.6.1ᙯҬቩࢗہ঩ཀـϐБԄǺཥቚႝηᔞǶ 7. The way of sending reviewers’ comments was

revised in item 5.6.1: “Electronic file” was added.

8. ܜඤߕҹ 6.1ǵ6.2ǵ6.5ǵ6.6ǵ6.7ǵ6.8ǹཥቚߕҹ

6.9Ȩቩࢗہ঩ᒦᒧ߄ȩϷ 5.10इᒵߥӸЎҹǶ

8. Appendices 6.1, 6.2, 6.5, 6.6, 6.7 and 6.8 were replaced; appendix 6.9 “Reviewers Selection Form”

was added; item 5.10 “Records Retention” was added.

20170709

2021.06.10

臺中榮民總醫院

參考文件

(5)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

F 15 1. ቚу 5.2.2.6ᇥܴϣ৒ȜऩࣁPTMS ҙፎਢ߾໻ሡ΢

໺ႝηᔞԿس಍ջёǴคሡӑрરҁǹऩߚ PTMS ҙፎਢ߾ሡᔠߕ٠ϩးܭќ΋ҽၗ਑֨Ǵቩֹࢗԋࡕ

߾ஒϩးЎҹଏᗋǶȝ

1. The following was added to item 5.2.2.6: 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 5.2.2.6ЎѡǺڙ၂ޣӕཀਜಃ 1।ڙ၂ޣၗૻǶ 2. Item 5.2.2.6 “the Informed Consent Form Page1:

subject’s information” was added.

3. অׯ 5.2.2.5߄ൂӜᆀǶ

3. The wording of the title of item 5.2.2.5 was revised.

4. ቚу 5.3.3ऩीฝЬ࡭Γۘคݤගٮԋ݀ൔ֋Ǵፎ୍

ѸᔠߕᇥܴǶ

4. Item 5.3.3 was added: If the PI is unable to submit a final report of the research results, an explanation has to be provided.

5. ቚу 5.4.3 ፁғᅽճ೽ڄЎวЎВයȨ҇୯ 103 ԃ

07 Д 28ВȩǶ

5. The issuance date of the letter from the Ministry of Health and Welfare “28 July 2014” was added in item 5.4.3.

6. ཥቚ 5.7.3཮᝼׫౻่݀Ȩਡ঑ȩਢҹǴऩࢂ཮᝼่

݀ϝԖࡌ᝼Ǵ܍ᒤΓ঩ሡӃගٮቩ่ࢗ݀ፎीฝЬ࡭

ΓӣᙟቩࢗཀـǴीฝЬ࡭ΓӣᙟЎҹҗ܍ᒤΓ঩ഋ ଌȐୋȑЬҺہ঩/୺ՉઝਜਡёࡕǴ܍ᒤΓ঩ωё а໒ҥȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩǶ

20190527

2021.06.10

臺中榮民總醫院

參考文件

(6)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

F 15 6. Item 5.7.3 was added: If the voting result on a protocol is “approved” and suggestions have been given on the protocol, the staff member should notify the PI of the review result and ask the PI to respond to reviewers’ comments. After the PI’s response has been compiled and submitted by the staff member to the (Vice) Chair/Executive Secretary and approved by the (Vice) Chair/Executive Secretary, the staff member may issue the “Approval of Human Research/Clinical Trial Study Closure.”

7. ཥቚ 5.7.4 ऩ׫౻่݀ࣁȨঅ҅ࡕਡ঑ȩǴीฝЬ࡭

ΓံҹȐӣᙟቩࢗཀـȑϺኧࣁ7ঁВ᏿ϺǴऩຬၸ 14 ঁВ᏿Ϻ߾೵Չᄖਢǹܭӣᙟයज़ډය߻Ǵҙፎ ΓԖ੝ਸ౛җǴளਜय़ҙፎۯߏӣᙟයज़ 14 ঁВ᏿

ϺǴа΃ԛࣁচ߾Ƕຬၸӣᙟයज़Ъᔕਜय़ҙፎۯߏ ӣᙟයज़ϐਢҹǴஒӃഋଌ୺ՉઝਜǵȐୋȑЬҺہ

঩ץҢࢂցӕཀڙ౛Ƕ܍ᒤΓ঩ഋଌȐୋȑЬҺہ঩

/୺ՉઝਜਡёࡕǴ܍ᒤΓ঩ωёа໒ҥȨΓᡏࣴز/

၂ᡍीฝ่ਢ೯ޕȩǶ

7. Item 5.7.4 was added: “If the voting result is

“approved after revision,” the PI should submit supplementary documents (or respond to reviewers’

comments) within 7 calendar days. The protocol will be withdrawn from IRB consideration if the PI does not respond within 14 calendar days. Before the due day, the PI may request extension of up to 14 calendar days under special circumstances.

The PI may request for extension only once. If the PI intends to request for extension after the deadline for requesting for extension is past, the case should be submitted to the Executive Secretary and the (Vice) Chair for approval. The staff member will issue the Approval of Human Research/Clinical Trial Study Closure after the case has been submitted to and approved by the (Vice) Chair/Executive Secretary.

20190527

2021.06.10

臺中榮民總醫院

參考文件

(7)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

F 15 8. অׯচ 5.7.3ϐ኱ဦࣁ5.7.5Ƕ

8. The original item number 5.7.3 was changed to 5.7.5.

9. ܜඤߕҹ 6.1ǵ6.4ǵ6.7Ƕ

9. Appendices 6.1, 6.4 and 6.7 were replaced.

10.Ӣᔈ IRB คરϯଌቩբ཰ǴঅׯᆶȨਜय़ၗ਑ȩ࣬

ᜢϐϣ৒Ƕ

10. Process related to hardcopies was revised to comply with the new IRB policy of paperless submission.

20190527

G 14 1. ཥቚ߄ൂӜᆀǺȨPTMS่ਢൔ֋ቩࢗཀـ߄ȩǶ

1. Document title was added: “PTMS Review Checklist for Closing Report.”

2. অׯ5.5.4.1 ΋૓ቩࢗϐቩ่ࢗ݀Ƕ

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

3. অׯ5.5.4.2 ᙁܰቩࢗϐቩ่ࢗ݀Ƕ

3. Revised the review decision of Expedited Review in item 5.5.4.2.

4. অׯ5.6.3Ϸ5.7.4ϐीฝЬ࡭Γӣᙟයज़ࣁ28ঁВ

᏿ϺǴ٠մନҙፎ৖ۯᇥܴЎӷǶ

4. Item 5.6.3 and 5.7.4 were revised the PI's reply period to 28 calendar days, and deleted the description of the extension.

5. ܜඤߕҹ 6.1ǵ6.3ǵ6.6ǵ6.9Ƕ

5. Appendices 6.1, 6.3, 6.6 and 6.9 were replaced.

20210528

2021.06.10

臺中榮民總醫院

參考文件

(8)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

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

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

G 14 6. ܜඤߕҹ 6.1ǵ6.3ǵ6.6ǵ6.9Ƕ

6. Appendices 6.1, 6.3, 6.6 and 6.9 were replaced.

20210528

ुঅቲ

Composed/Revised/Deleted

ቩਡ

Reviewed

ਡ঑

Approved

ɁᆅڋЎҹόளᏰԾ༡ׯϷ଺૶ဦ٠࿣ЗቹӑǶ

ɁҁЎҹаKMس಍ࣁനཥހҁǴરҁวՉሡ࿶SOPᆅ౛ύЈਡകǴᝄ࿣ԾՉӈӑǶ

Ɉ

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

Ɉ

ɈThe 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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ᆅ ڋ Ў ҹ ु অ ቲ ཮ ቩ ൂ

Review Form of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB-Regulations of Operation-2013

ЎҹӜᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ

SOP for Study Closure

཮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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(10)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 1/14 ހԛ

Version G ހ 1.Ҟޑ

ࣁගٮӃ߻೯ၸቩࢗϐीฝਢǴځ่ਢൔ֋ϐᛦҬǵଓᙫکቩࢗբ཰

ё٩ൻϐೕጄǴ੝ुۓҁᆅ౛ำׇਜǶ 1. Purpose

The purpose of this SOP is to describe the procedure for the submission of closing reports and the review and monitoring of study closure of approved protocols.

2.፾Ҕጄൎ

፾Ҕܭ၂ᡍीฝ୺Չ೚ёਜډයǴЪ҂ҙፎۯߏ၂ᡍ୺Չයज़Ǵ၀ी

ฝЬ࡭ΓሡӵයᛦҬ่ਢൔ֋ϐीฝǶ 2. Scope

This SOP applies to the protocols for which the approval period has expired and an extension application has not been submitted. For these protocols, the PIs should submit closing reports before the due date.

3.ୖԵЎҹ คǶ

3. References None.

4.Ӝຒۓက คǶ

4. Definitions None.

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(11)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 2/14 ހԛ

Version G ހ 5.բ཰ϣ৒

5. Procedure

5.1ीฝ่ਢቩࢗᆅ౛ࢬำკ

5.1 Flow Chart of Study Closure Review

ࢬำ Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ Relevant Documents

Yes

অ҅ࡕ௢ᙚ Approval after

revision

໪ග཮૸ፕ Send to full board

ਡ঑

Approval No

่ਢൔ֋ᛦҬ Submission of Closing Report

ଌቩЎҹዴᇡ Confirmation of

Submission

،ۓቩࢗБԄ Ϸᒦᒧቩࢗہ঩

Review Category &

Selection of Reviewers

ہ঩ቩࢗ

Review

ीฝЬ࡭Γӣᙟ Response by PI

অ҅ࡕӆቩ Further review

after revision

ε཮ቩࢗ

Board Meeting

่ਢ೯ޕ໒ҥϷਡഢ Issuance of Approval of

Study Closure

इᒵߥӸ Records Retention

অ҅

Revision

௢ᙚ Approval

ीฝЬ࡭Γ Principal Investigator

ीฝ่ਢൔ֋࣬ᜢ߄ൂ

Relevant forms for closing reports

܍ᒤΓ঩

Staff Members

่ਢൔ֋/ਢҹࢬำ߄ Closing reports/Protocol

Review Routing Form

୺Չ઎ਜ/

ȐୋȑЬҺہ঩

Executive Secretary/

(Vice) Chair

ଌቩЎҹ

Submission documents

ቩࢗہ঩

Reviewers

่ਢၗ਑/PTMS่ਢൔ֋ቩࢗཀـ߄ Study closure documents/

PTMS Review Checklist for Closing Report

ीฝЬ࡭Γ Principal Investigator

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩

཮ቩࢗཀـӣᙟ߄ Form of Response to IRB

Reviewers’ Comments ہ঩

Reviewers

཮᝼इᒵ Meeting Minutes

܍ᒤΓ঩/୺Չ઎ਜ/

ȐୋȑЬҺہ঩

Staff Members/ Executive Secretary/(Vice) Chair

ϦЎ/Γᡏࣴز/၂ᡍीฝ่ਢ೯ޕ Official Correspondence/

Approval of Clinical Trial Study Closure

܍ᒤΓ঩

Staff Members

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 3/14 ހԛ

Version G ހ 5.2่ਢൔ֋ᛦҬ

5.2 Submission of Closing Report

5.2.1ीฝЬ࡭Γྗഢ่ਢൔ֋ЎҹǶ

5.2.1 The PI should submit the closing report.

5.2.2ीฝЬ࡭Γഢִ܌໪่ਢൔ֋ၗ਑ӵΠǺ

5.2.2 The PI should submit the closing report along with the following documents:

5.2.2.1่ਢଌҹਡჹ߄Ƕ

5.2.2.1 Study Closure Submission Checklist

5.2.2.2 ่ਢൔ֋߄/ PTMS ่ਢҙፎਜȐҙፎΓሡᛝӜǴӵԖ

ԋ݀ൔ֋ፎߕ΢ȑǶ

5.2.2.2 Closing Report Form/PTMS Study Closure Application Form (The PI should sign on the form. Submit the final report with research results if applicable.)

5.2.2.3ҁ཮୺Չ೚ёਜ/ଓᙫቩࢗ೚ёਜ/অ҅ਢӕཀڄቹҁǶ

5.2.2.3 Photocopy of the Certificate of Approval/Certificate of Project Extension/Certificate of Protocol Amendment issued by TCVGH IRB.

5.2.2.4ڙ၂ޣమൂᆶԏਢރݩඔॊ߄Ƕ

5.2.2.4 List of Subjects and Description of Subject Enrollment.

5.2.2.5ᝄख़όؼ٣ҹ೯ൔइᒵ߄(໻೯ൔSUSAR)Ƕ

5.2.2.5 Serious Adverse Event Report Form (only SUSAR is reported)

5.2.2.6Ȩڙ၂ޣӕཀਜȩϷڙ၂ޣϭᒧ໨Ҟ।य़ႝηᔞ܈ቹҁ Ȝ؂΋ཥހᔈߕ΋ҽֹ᏾ޑȨڙ၂ޣӕཀਜȩቹҁǴځ дߕڙ၂ޣӕཀਜಃ1।ڙ၂ޣၗૻǵᛝӜ।ϷԖڙ၂ ޣϭᒧ໨Ҟ।य़ϐቹҁջёȐቹӑȨڙ၂ޣӕཀਜȩਔǴ ሡाڙ၂ޣϭᒧ໨Ҟޑϣ৒೿ाቹӑȑǶȨڙ၂ޣӕཀ ਜȩᕴҽኧեܭȐ֖ȑ30 ҽϐीฝਢǴ໪ӄኧᛦҬȨڙ

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 4/14 ހԛ

Version G ހ ၂ޣᛝ࿿ӕཀਜȩଌҁ཮ቩࢗǹऩȨڙ၂ޣӕཀਜȩᕴ ҽኧεܭ 30 ҽϐीฝਢǴ٩ڙ၂ޣమൂϐȨӕཀਜȩ ᛝ࿿Вය฻ຯКٯȐڙ၂ޣᕴኧନа 30ȑܜрǴа 30 ҽࣁज़ǶಃΒԃ໒ۈϐଓᙫቩࢗਢ໻ሡᛦҬཥԏਢ܈ཥ ᛝ࿿ϐȨڙ၂ޣӕཀਜȩಃ1।ڙ၂ޣၗૻǵᛝӜ।Ϸ ڙ၂ޣϭᒧ।ቹҁǹऩࢂ҂યΕཥঁਢЪ҂Ԗཥᛝ࿿ϐ Ȩڙ၂ޣӕཀਜȩǴ໻ሡᛦҬӄ೽Ȩڙ၂ޣమൂȩջёȝǶ ȜऩࣁPTMSҙፎਢ߾໻ሡ΢໺ႝηᔞԿس಍ջёǴค ሡӑрરҁǹऩߚPTMSҙፎਢ߾ሡᔠߕ٠ϩးܭќ΋

ҽၗ਑֨Ǵቩֹࢗԋࡕ߾ஒϩးЎҹଏᗋǶȝ

5.2.2.6 A photocopy or electronic file of the pages with the subjects’ signatures and checklists on the ICF. For each new version of the ICF, submit a photocopy of the complete 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.

Ȝ For non-PTMS applications, hard copies of submission documents should be included in a separate binder. The binder will be returned to the PI

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 5/14 ހԛ

Version G ހ after the review is completed.ȝ

5.2.2.7ځдǶ 5.2.2.7 Others.

5.2.3ऩीฝЬ࡭Γ҂ܭ೚ёਜډය߻ගрਏය৖ۯϐҙፎǴᔈܭ

೚ёਜډයࡕΟঁДϣᛦҬȨ่ਢൔ֋ȩǴց߾ȐୋȑЬҺ ہ঩Ԗ៾،ۓኩόڙ౛ځཥਢҙፎǶ

5.2.3 If the PI has not applied for a continuing review before the Certificate of Approval expires, the PI should submit a closing report within three months after the Certificate of Approval expires. Otherwise, the (Vice) Chair may determine that new protocol submissions from the PI will not be accepted by the IRB.

5.2.4ଌҁ཮ቩࢗϐीฝਢǴ೚ёਜϐԖਏයज़ၸයϤঁДࡕǴ҂

ଌȨ่ਢൔ֋ȩϒҁ཮ቩࢗϐीฝЬ࡭ΓǴኩόڙ౛ཥਢቩ

ࢗǴߩځ่ਢൔ֋ᛦҬࡕǴۈڙ౛ཥਢቩࢗǶ

5.2.4 If the PI does not submit the closing report within six months after the Certificate of Approval expires, then any new protocol submission from the PI will not be accepted by the IRB until a closing report is submitted.

5.2.5୺Չ೚ёਜၸයЪຬၸ 3ԃ҂ᛦҬଓᙫቩࢗൔ֋ϐਢҹǴ܍

ᒤΓ঩ளගε཮ൔ֋Ǵ٩ε཮،᝼ೀ౛ࡕុ࣬ᜢ٣ەȐӵჴ ӦೖࢗǵՉࡹ่ਢ٠ࡌ᝼Ь࡭Γௗڙ௲ػ૽ግ…฻،᝼ȑǶ 5.2.5 If the PI does not submit a continuing review report within

three years after the Certificate of Approval expires, the staff member may place the protocol on the agenda for the IRB board meeting. The IRB board meeting will make a resolution on follow-up actions (such as conducting a monitoring visit or administrative closure of the study, suggesting the PI to receive training, or other actions).

5.3ଌቩЎҹዴᇡ

5.3 Confirmation of Submissions

5.3.1܍ᒤΓ঩ਡჹȨଌቩЎҹȩǴନीฝ่ਢൔ֋߄/ PTMS ่ਢ

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 6/14 ހԛ

Version G ހ ҙፎਜѦǴᔈᔠߕѸഢЎҹ˰ҁ཮୺Չ೚ёਜ/ଓᙫቩࢗ೚ё ਜ/অ҅ਢӕཀڄቹҁǵڙ၂ޣమൂǵᝄख़όؼ٣ҹ೯ൔइᒵ ߄(໻೯ൔ SUSAR)˱Ƕ

5.3.1 The staff member should verify that the submitted documents are complete. In addition to the Closing Report Form/PTMS Study Closure Application Form, other required documents need to be included ˰photocopy of Certificate of Approval/Certificate of Project Extension/Certificate of Protocol Amendment issued by TCVGH-IRB, List of Research Subjects, and Serious Adverse Event Report Form (only SUSAR is reported)˱.

5.3.2ၗ਑ሸӄࡕǴ܍ᒤΓ঩ڙ౛ҙፎᒤ౛Ƕ

5.3.2 After compiling the submission documents, the staff member process the application.

5.3.3ऩीฝЬ࡭Γۘคݤගٮԋ݀ൔ֋Ǵፎ୍ѸᔠߕᇥܴǶ

5.3.3 If the PI is unable to submit a final report of the research results, an explanation has to be provided.

5.4،ۓቩࢗБԄϷᒦᒧቩࢗہ঩

5.4 Decision on Review Category and Selection of Reviewers

5.4.1চ߾΢ଌচቩࢗہ঩ቩࢗǴऩচቩࢗہ঩ςߚ౜Һہ঩܈ځ

д੝ਸ௃ݩǴ߾җ୺Չઝਜࡰࢴ΋Տہ঩жࣁቩࢗǶ

5.4.1 The submission should be reviewed by the original reviewer of the protocol. If the original reviewer does not serve as an IRB member or under other special circumstances, the Executive Secretary may assign another member to review the submission.

5.4.2 ҂ԏਢϐ่ਢൔ֋ёҗ୺Չ઎ਜǵȐୋȑЬҺہ঩ӕཀࡕǴ

ள٩ՉࡹำׇӃ๏ϒਡวȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩϷ ϦЎ٠ܭε཮ଓᇡǶ

5.4.2 The closing report of a protocol which has not recruited subjects may be approved by the Executive Secretary and the (Vice) Chair to be issued the “Approval of Study

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 7/14 ހԛ

Version G ހ Closure” with an official notice by the administrative procedure, which will be confirmed in the IRB board meeting.

5.4.3Ȩཥਢȩऩ࿶΋૓ቩࢗำׇǴࡕុϐᅱ࿎ᆅ౛Ȑջଓᙫቩࢗǵ

অ҅ਢǵ่ਢ…฻ȑǴҭӕࣁ΋૓ቩࢗำׇࣁϐȐ҇୯ 103 ԃ 07Д 28Вፁғᅽճ೽ፁ೽ᙴӷಃ1030120703 ဦڄȑǶ ϸϐǴऩ࿶ᙁܰቩࢗำׇǴ߾ࡕុᅱ࿎ᆅ౛Ǵள௦Չᙁܰቩ

ࢗำׇǶ

5.4.3 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, study closure, etc.) should be sent to the full board for review as well (in compliance with the regulation 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 may be conducted by the expedited review process.

5.5ہ঩ቩࢗ

5.5 Review

5.5.1܍ᒤΓ঩ஒሸӄϐȨ่ਢၗ਑ȩଌہ঩ቩࢗǶہ঩ᔈ٩ྣ၂

ᡍϐ୷ҁউ౛চ߾຾ՉቩࢗǴዴۓ၂ᡍϐ୺Չ֡಄ӝᔈԖำ

ׇᆶჹڙ၂ޣϐߥៈǶ

5.5.1 The staff member should compile submitted study closure documents and submit them to IRB members for review.

The reviewer should conduct the review according to the basic ethics principles of clinical trials and ensure that the implementation of the trial has complied with required procedures and has protected the rights of the research subjects.

5.5.2ࣴزीฝ୺Չ่״ࡕǴہ঩ᔈዴᇡࣴزი໗ዴჴ୺Չڙ၂ޣ

ᗦدϷёᒣ᛽ၗ਑ᐒஏϐߥៈ௛ࡼǶ

5.5.2 The reviewer should evaluate if the PI and research

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Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 8/14 ހԛ

Version G ހ personnel have protected the privacy of the subjects and kept identifiable data confidential even after a research project has been completed.

5.5.3ቩࢗว౜ୃᚆǵӒϷڙ၂ޣғڮӼӄ܈ځдၴϸ၂ᡍউ౛௃

׎Ǵ໪ҥջೀ౛ޣǴёፎȐୋȑЬҺہ঩є໒ᖏਔ཮᝼ǹߚ ᆙ࡚௃ݩǴёा؃ीฝЬ࡭ΓܭΠ΋ԛε཮ਔډ൑ᇥܴǴѸ

ाਔӼ௨ჴӦೖࢗǶ

5.5.3 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.

5.5.4ीฝਢϐቩࢗᜪࠠࣁ΋૓ቩࢗϷᙁܰቩࢗǶ

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

5.5.4.1 ΋૓ቩࢗ

5.5.4.1 Full Board Review

a.ऩቩ่ࢗ݀ࣁȨࡌ᝼೯ၸȩЪόሡӣᙟϐीฝǴ߾ޔௗ

௨Εന߈΋ԛε཮᝼ำਡഢǶ

a. If the review decision is “recommended” and no response is required, then the protocol should be placed on the agenda for the next scheduled board meeting for confirmation.

b.ځہ঩ቩࢗޑ่݀ࣁȨࡌ᝼অ҅܈ගٮ຾΋؁ᇥܴȩǴ

ीฝЬ࡭Γᔈܭज़යϣӣᙟቩࢗཀـǴ܍ᒤΓ঩༼᏾ၗ

਑ࡕஒ၀ਢҹևଌΕ཮ץҢൂϒ୺Չ઎ਜǵȐୋȑЬҺ ہ঩ቩਡǴऩቩਡޑ่݀ࣁȨӕཀ௨Εന߈΋ԛޑε཮

ਡഢȩǴ߾ޔௗ௨Εന߈΋ԛε཮᝼ਡഢǶ

b. If the review decision is “recommended for revision or

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(18)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 9/14 ހԛ

Version G ހ 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 protocol should be placed on the agenda for the next scheduled IRB board meeting for confirmation.

c.ځہ঩ቩࢗޑ่݀ࣁȨࡌ᝼ό೯ၸ)ග཮૸ፕ*ȩǴीฝ Ь࡭Γᔈܭज़යϣӣᙟቩࢗཀـǴ܍ᒤΓ঩༼᏾ၗ਑ࡕ ௨Εന߈΋ԛε཮᝼ำ૸ፕǶ

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 protocol on the agenda for the next scheduled IRB board meeting for discussion.

5.5.4.2 ᙁܰቩࢗ

5.5.4.2 Expedited Review

a.ځہ঩ޑቩ่ࢗ݀ऩࣁȨࡌ᝼অ҅܈ගٮ຾΋؁ᇥܴȩǴ

ीฝЬ࡭Γᔈܭज़යϣӣᙟቩࢗཀـϷᔠଌ׳҅ߕҹǴ ऩቩࢗཀـຏܴȨঅ҅ࡕӆቩȩǴ܍ᒤΓ঩ӆஒीฝЬ

࡭Γϐӣᙟཀـᙯፎቩࢗہ঩ӆԛຑਡǶ

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.ځہ঩ޑቩ่ࢗ݀ऩࣁȨό಄ӝᙁܰቩࢗǴׯଌ΋૓ቩ

ࢗȩǴीฝЬ࡭Γᔈܭज़යϣӣᙟቩࢗཀـǴ܍ᒤΓ঩

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(19)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 10/14 ހԛ

Version G ހ

༼᏾ၗ਑ࡕ௨Εന߈΋ԛε཮᝼ำ૸ፕǶ

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 protocol on the agenda for the next scheduled IRB board meeting for discussion.

c.ځہ঩ޑቩ่ࢗ݀ऩࣁȨ೯ၸȩЪόሡीฝЬ࡭Γӣᙟ ϐीฝǴ߾܍ᒤΓ঩ᔈӃஒ၀ਢҹևଌ୺Չ઎ਜǵȐୋȑ ЬҺہ঩ቩਡࡕਡว೚ёਜ٠ගԿε཮ଓᇡǶ

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 study closure is approved, an Approval of Study Closure should be issued, and the study closure approval should be submitted to the board meeting for confirmation.

5.6ीฝЬ࡭Γӣᙟ

5.6 The PI’s Response to Reviewers’ Comments

5.6.1྽ቩࢗہ঩ԖཀـਔǴ܍ᒤΓ঩ᔈᗦѐቩࢗޣۉӜ٠ஒཀـ

ϣ৒аႝηᔞҬଌीฝЬ࡭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.

5.6.2.໪ӣᙟہ঩ቩࢗཀـϐਢҹǴीฝЬ࡭Γܭज़යϣӣᙟቩࢗ

ཀـࡕǴ܍ᒤΓ঩ᔈӃஒ၀ӣᙟևଌ୺Չ઎ਜǵȐୋȑЬҺ 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

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(20)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 11/14 ހԛ

Version G ހ 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 days, the protocol should be withdrawn from IRB consideration.

5.7ε཮ቩࢗ

5.7 IRB Board Meeting

5.7.1ہ঩ᔈቩ཈Ӧ૸ፕϷቩࢗȨ่ਢൔ֋ȩǶ

5.7.1 IRB members should thoroughly discuss and review closing reports.

5.7.2࿶૸ፕࡕǴऩคҺՖہ঩Ԗ౦᝼Ǵ߾ϒаਡഢǶ

5.7.2 Study closure is approved when all members come to a consensus to approve it after discussion.

5.7.3཮᝼׫౻่݀Ȩਡ঑ȩਢҹǴऩࢂ཮᝼่݀ϝԖࡌ᝼Ǵ܍ᒤ

Γ঩ሡӃගٮቩ่ࢗ݀ፎीฝЬ࡭ΓӣᙟቩࢗཀـǴीฝЬ

࡭ΓӣᙟЎҹҗ܍ᒤΓ঩ഋଌȐୋȑЬҺہ঩/୺Չઝਜਡё ࡕǴ܍ᒤΓ঩ωёа໒ҥȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩǶ 5.7.3 If the voting result of the board meeting is ‘approval’ with

further comments, then the staff member should notify the PI of the comments from the board meeting and request the PI to respond to the comments. After the PI’s response to comments has been received and approved by the (Vice) Chair/Executive Secretary, then the staff member may issue the Approval of Study Closure.

5.7.4 ऩ׫౻่݀ࣁȨঅ҅ࡕਡ঑ȩǴीฝЬ࡭ΓံҹȐӣᙟቩࢗ

ཀـȑϺኧࣁ7ঁВ᏿ϺǴऩຬၸ28ঁВ᏿Ϻϝ҂ӣᙟ߾೵

ՉᄖਢǶ܍ᒤΓ঩ഋଌȐୋȑЬҺہ঩/୺ՉઝਜਡёࡕǴ܍

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(21)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 12/14 ހԛ

Version G ހ ᒤΓ঩ωёа໒ҥȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩǶ

5.7.4 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 days, the protocol should be withdrawn from IRB consideration. The staff member will issue the Approval of Clinical Trial Study Closure after the case has been submitted to and approved by the (Vice) Chair/Executive Secretary.

5.7.5 ऩε཮׫౻่݀ࣁȨόਡ঑ȩǴ߾٩ε཮ߕ஥،᝼ȐӵǺჴ

Ӧೖࢗ฻ȑᒤ౛ࡕុ࣬ᜢ٣ەǶ

5.7.5 If the voting result is “disapproval,” then the staff member should notify the PI of the resolution. Follow-up actions may be taken according to the board meeting resolution (e.g. conducting an on-site monitoring visit).

5.8่ਢ೯ޕ໒ҥϷਡഢ

5.8 Issuance of Approval of Study Closure

่ਢൔ֋ቩࢗӕཀࡕǴ܍ᒤΓ঩ഋଌ୺Չ઎ਜǵȐୋȑЬҺہ঩

ᙟਡӕཀਡวȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩǶ

Once the closing report of an expedited review protocol has been reviewed and approved, the staff member may issue the Approval of Study Closure with the confirmation of the Executive Secretary and (Vice) Chair.

5.9 ࿶཮᝼،᝼ӕཀ่ਢޣǴ܍ᒤΓ঩ё໒ҥȨΓᡏࣴز/၂ᡍीฝ

่ਢ೯ޕȩǶ

5.9 Once the study closure of a full board review protocol has been approved by the IRB board meeting resolution, the staff member may issue the Approval of Study Closure.

5.10इᒵߥӸ

࣬ᜢΓ঩ᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚ໨इᒵǶ 5.10 Records Retention

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

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參考文件

(22)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

।ԛ

Page 13/14 ހԛ

Version G ހ

ጓဦ Number

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period 1 ่ਢଌҹਡჹ߄

Study Closure Submission Checklist

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed 2

่ਢൔ֋߄/ PTMS่ਢҙፎਜ Closing Report Form/PTMS Study Closure Application Form

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed 3

ڙ၂ޣమൂᆶԏਢރݩඔॊ߄ List of Subjects and Description of Enrollment

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed

4

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

5

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮่ਢൔ

֋ਢҹቩࢗख़ᗺݙཀ٣໨ᔠਡ߄/PTMS

่ਢൔ֋ቩࢗཀـ߄

IRB Review Checklist for Closing Report/PTMS Review Checklist for Closing Report

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed

6

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ቩࢗཀ ـӣᙟ߄

Form of Response to IRB Reviewers’

Comments

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed

7 ਢҹࢬำ߄

Protocol Review Routing Form

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed 8 Γᡏࣴز/၂ᡍीฝ่ਢ೯ޕ

Approval of Study Closure

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed 9 ቩࢗہ঩ᒦᒧ߄

Reviewers Selection Form

IRBᔞਢ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed

6.ߕҹ

ȨPTMS่ਢҙፎਜȩǵȨPTMS่ਢൔ֋ቩࢗཀـ߄ȩǵȨϦЎȩࣁ

ጕ΢س಍ᒡΕǴคހҁᇤҔϐဤǴࡺόӈΕߕҹᆅ౛Ƕ 6. Appendices

“PTMS Study Closure Application Form”, “PTMS Review

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參考文件

(23)

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2013

IRB -Regulations of Operation-2013

Ўҹ Ӝᆀ

Title

่ਢቩࢗᆅ౛ำׇਜ SOP for Study Closure

Page 14/14 ހԛ

Version G ހ Checklist for Closing Report” and “Official Correspondence” are generated from the online system, preventing the usage of the wrong version; therefore, the documents are not listed as an appendix.

6.1่ਢଌҹਡჹ߄

6.1 Study Closure Submission Checklist 6.2่ਢൔ֋߄

6.2 Closing Report Form

6.3ڙ၂ޣమൂᆶԏਢރݩඔॊ߄

6.3 List of Subjects and Description of Enrollment 6.4ᝄख़όؼ٣ҹ೯ൔइᒵ߄(໻೯ൔ SUSAR)

6.4 Serious Adverse Event Report Form (only SUSAR is reported) 6.5 ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮่ਢൔ֋ਢҹቩࢗख़ᗺݙཀ٣

໨ᔠਡ߄

6.5 IRB Review Checklist for Closing Report

6.6ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ቩࢗཀـӣᙟ߄ 6.6 Form of Response to IRB Reviewers’ Comments 6.7ਢҹࢬำ߄

6.7 Protocol Review Routing Form 6.8Γᡏࣴز/၂ᡍीฝ่ਢ೯ޕ 6.8 Approval of Study Closure 6.9ቩࢗہ঩ᒦᒧ߄

6.9 Reviewers Selection Form

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