ᆵ ύ ᄪ ҇ ᕴ ᙴ ଣ ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄ - 台中榮總

(1)

T a 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-2005

IRB-Regulations of Operation- 2005

ЎҹӜᆀ

Title

஑ৎቩࢗᆅ౛ำׇਜ

SOP for Review by Expert Consultants

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ ɍஏҹ 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 4 ཥुǶNewly composed. 20140519 B 3 җΓᡏ၂ᡍہ঩཮኱ྗբ཰ำׇ5.4 ހᙯඤԋԜހҁ

This version was converted from “Version 5.4 of the Standard Operating Procedure of the Human Research Committee.”

20141125

C 3 1. চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ȩǶ 1. The original “Human Research Committee” was

renamed “The First/Second IRB Committees”

2.চȨᐱҥ஑ৎȩ׳ӜࣁȨ஑ৎȩǺЎҹӜᆀǵ4.1 Ӝຒۓ

ကǵ5.1 ࢬำკϐ៾ೢϷϣЎǶ

2. The original “independent expert” was changed into “expert consultant” in the title of this document, in item 4.1 Definitions, and in item 5.1 Flow Chart (in “Responsible Personnel” and in the content of the flow chart).

3.մନচߕҹ6.1ᐱҥ஑ৎᔞਢǶ

3. Deleted the original Appendix 6.1 “Portfolio of Independent Experts.”

20160318

C 3 ٩ҁଣೕۓǴܭ2017ԃ 6Д 29Вख़ཥቩຎҁЎҹǴϣ৒

ค໪অׯǶ

Complied with the regulations of TCVGH, this document was re-examined on 29 June, 2017, and the content did not need to be revised.

20160318

D 3 ཥቚ 5.4.4Ȩ஑ৎளрৢε཮ǵගрቩࢗཀـൔ֋ǵୖᆶ૸

ፕǴՠόૈ׫౻Ƕȩ

Added item 5.4.4 “Expert consultants may attend IRB board meetings to give reports on reviewers’ comments and

participate in discussion, but they may not vote at the meetings.”

20180529

E 6 1.׳ཥୖԵЎҹ3.1ࣁ 2011ԃǶ

1. Updated the year of reference 3.1 to 2011.

2.অׯୖԵЎҹ3.2ࣁȨInternational Conference on Harmonization of Good Clinical Practice Guidelines (ICH GCP) 2016ȩǶ

2. Revised reference 3.2 into “International Conference on Harmonization of Good Clinical Practice Guidelines (ICH GCP), 2016.”

20181026

2020.11.17

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(2)

T a 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

ЎҹӜᆀ

Title

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ ɍஏҹ 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 6 3. ٩Ᏽ FERCAP୯ሞೖຎϐࡌ᝼ǴཥቚୖԵЎҹ 3.3ȨThe

Council for International Organizations of Medical Sciences (CIOMS), International ethical guidelines for health-related research involving humans, 2016ȩǶ

3. Following the suggestions made by site-visit reviewers of FERCAP, reference 3.3 “The Council for International Organizations of Medical Sciences (CIOMS), International ethical guidelines for health-related research involving humans, 2016” was added.

20181026

E 6 ٩ҁଣೕۓǴܭ 2020ԃ 09Д 20Вख़ཥቩຎҁЎҹǴϣ

৒ค໪অׯǶ

Complied with the regulations of TCVGH, this document was re-examined on 20 September, 2020, and the content did not need to be revised.

20181026

ुঅቲ

Composed/Revised/Deleted

ቩਡ

Reviewed

ਡ঑

Approved

ɁᆅڋЎҹόளᏰԾ༡ׯϷ଺૶ဦ٠࿣ЗቹӑǶ

ɁҁЎҹаKMس಍ࣁനཥހҁǴરҁวՉሡ࿶SOPᆅ౛ύЈਡകǴᝄ࿣ԾՉӈӑǶ

䈜

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

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.

ҁЎҹς࿶៾ೢЬᆅ҅Ԅਡ঑Ǵ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅ౛ύЈ

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䈜ፎӚ཮ᒤൂՏЬᆅඁ፥ቩࢗཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐ୘Ƕ

䈜

䈜The 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.

Ta ichung Ve te ra ns Gene ra l Hospital

ᆅ ڋ Ў ҹ ु অ ቲ ཮ ቩ ൂ

Review Form of Composition and Revisions of Controlled Documents Ўҹጓဦ

Document Number

ЎҹӜᆀ

Title

཮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.

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Taichung Veterans General Hospital

Ўҹጓဦ

Document Number

IRB-Regulations of Operation-2005

Ўҹ Ӝᆀ

Title

।ԛ

Page 1/6

ހԛ

Version Eހ

1.Ҟޑ

ࣁߦ٬ҁଣಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ගٮ஑ৎڐշीฝਢቩ

ࢗ܈ගٮᒌ၌ϐᆅ౛Ԗ΋ܴዴϐೕጄǴ੝ڋुҁᆅ౛ำׇਜǶ 1. Purpose

The purpose of this SOP is to provide specific guidelines for the management of expert consultants reviewing research protocols or giving advice.

2.፾Ҕጄൎ

Υҁଣಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ȐୋȑЬҺہ঩ᇡࣁीฝਢ

ࣴزϐ᝼ᚒߚہ঩஑཰ሦୱ܈Ӹӧ໪ճ੻଑ᗉޑ௃ݩਔǴёаᗎፎ ଣϣ܈ଣѦځд੝ਸ஑཰ሦୱϐ஑ৎڐշቩࢗ܈ගٮ஑཰ޑᒌ၌ϐ ᆅ౛֡፾Ҕҁᆅ౛ำׇਜǶ

2. Scope

This SOP applies to the situation in which expert consultants with special expertise from within or outside TCVGH are invited to review a research protocol or provide professional advice when the IRB (Vice) Chair considers that the topic of the research

protocol does not correspond to the professional disciplines of IRB members, or if there is a conflict of interest.

3.ୖԵЎҹ 3. References

3.1 World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, 2011.

3.2 International Conference on Harmonization of Good Clinical Practice Guidelines (ICH GCP), 2016.

3.3 The Council for International Organizations of Medical Sciences (CIOMS), International ethical guidelines for health-related research involving humans, 2016.

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 2/6

ހԛ

Version Eހ

4.Ӝຒۓက 4. Definitions

4.1஑ৎ

ࣁόୖᆶ၀໨ࣴزޑଣϣ܈ଣѦΓ঩ǴගٮࣴزीฝϦ҅ޑࡌ᝼

ϷຑፕǶ

4.1 Expert Consultant

Expert consultants are personnel from within or outside TCVGH, who are not involved in a study and can provide impartial suggestions and comments about the study protocol.

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 3/6

ހԛ

Version Eހ

5.բ཰ϣ৒

5. Procedure

5.1஑ৎቩࢗᆅ౛ࢬำკ

5.1 Flow Chart of the SOP for Review by Expert Consultants

ࢬำ

Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ

Relevant Documents

ௗᕇ஑ৎቩࢗሡ؃

Need of Review by Expert Consultants

ڐշीฝਢቩࢗ

Reviewing Protocols

इᒵߥӸ Records Retention

௢ᙚᆶᒦᒧ Recommendation and

Selection

܍ᒤΓ঩

Staff Members

ہ঩/୺Չઝਜ/

(ୋ)ЬҺہ঩

IRB Members/

Executive Secretary/

(Vice) Chair

ঁΓ୷ҁၗ਑/Οԃϣᖏ׉၂ᡍ࣬

ᜢ૽ግ᛾ܴਜቹҁ/ᛝ࿿ߥஏǵճ੻

ፂँڐ᝼ਜ/ငਜ/஑ৎᔞਢ Personal Information/Copies of Training Certificates on Clinical Trials within Three Years/Signed Statements

of Confidentiality and Conflict of Interest/Contracts/Files of Expert

Consultants

஑ৎ

Expert Consultants

ࣴزीฝၗ਑

Documents of Research Protocols

܍ᒤΓ঩

Staff Members

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 4/6

ހԛ

Version Eހ 5.2ௗᕇ஑ৎቩࢗሡ؃

྽ȐୋȑЬҺہ঩ᇡࣁीฝਢࣴزϐ᝼ᚒߚہ঩஑཰ሦୱǴ܈Ӹ ӧ໪ճ੻଑ᗉޑ௃ݩਔǴёаᗎፎଣϣ܈ଣѦځд੝ਸ஑཰ሦୱ ϐ஑ৎڐշቩࢗ܈ගٮ஑཰ޑᒌ၌Ƕ

5.2 Need of Review by Expert Consultants

If the (Vice) Chair considers that the topic of a research protocol does not match the expertise of IRB members, or if there is conflict of interest, expert consultants with relevant expertise from within or outside TCVGH may be invited to review the protocol or provide professional advice.

5.3௢ᙚᆶᒦᒧ

5.3 Recommendation and Selection

5.3.1ہ঩ǵ୺ՉઝਜǵୋЬҺہ঩܈ЬҺہ঩ё٩ሡाᒿਔ௢ᙚ

஑཰ᒌ၌ΓᒧǶ

5.3.1 IRB members, Executive Secretary, Vice Chair, or Chair may recommend candidates of expert consultants anytime based on needs.

5.3.2ȐୋȑЬҺہ঩ቩຎ஑ৎϐ஑ߏǴቻ၌஑ৎཀᜫࡕǴፎ஑ৎ ගٮаΠၗ਑Ǻ

5.3.2 After reviewing the expertise of candidates for expert consultants and consulting with them about their

willingness to serve, the (Vice) Chair shall ask them to provide the following documents:

5.3.2.1ঁΓ୷ҁၗ਑Ƕ 5.3.2.1 Personal information

5.3.2.2Οԃϣᖏ׉၂ᡍ࣬ᜢ૽ግ᛾ܴਜቹҁǶ

5.3.2.2 Copies of training certificates on clinical trials within three years

5.3.2.3ᛝ࿿ߥஏ/ճ੻ፂँڐ᝼ਜǶ

5.3.2.3 Signed statements of confidentiality and conflict of

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 5/6

ހԛ

Version Eހ interest.

5.3.2.4ЬҺہ঩ठଌငਜǴငයϖԃǴයᅈளុငǶ

5.3.2.4 The Chair shall give a five-year renewable contract to each expert consultant.

5.3.2.5܍ᒤΓ঩ஒ஑ৎϐۉӜϷ஑ߏࡌᔞǶ

5.3.2.5 Staff members shall create a file with each expert consultant's name and expertise.

5.4ڐշीฝਢቩࢗ

5.4 Reviewing Protocols

5.4.1܍ᒤΓ঩ගٮȨࣴزीฝၗ਑ȩ๏஑ৎቩࢗǶ

5.4.1 Staff members shall provide expert consultants with relevant documents of research protocols for them to review.

5.4.2஑ৎቩࢗࣴزीฝࡕǴֹԋቩࢗཀـ߄ٮΓᡏࣴزউ౛ቩࢗ

ہ঩཮ቩਡǶ

5.4.2 Expert consultants shall fill out relevant reviewer’s forms and submit them to the IRB after reviewing protocols.

5.4.3஑ৎ܌଺ޑൔ֋Ǵᔈᆶځдቩࢗہ঩ϐൔ֋΋ӕӸᔞǶ

5.4.3 Reports by expert consultants shall be filed along with the reports by other reviewers.

5.4.4஑ৎளрৢε཮ǵගрቩࢗཀـൔ֋ǵୖᆶ૸ፕǴՠόૈ׫

౻Ƕ

5.4.4 Expert consultants may attend IRB board meetings to give reports on reviewers’ comments and participate in

discussion, but they may not vote at the meetings.

5.5इᒵߥӸ

࣬ᜢΓ঩ᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚ໨इᒵǶ 5.5 Records Retention

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

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 6/6

ހԛ

Version Eހ

6.ߕҹ คǶ 6. Appendix

None.

ጓဦ Document Number

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period

1 ஑ৎᔞਢၗ਑

Files of Expert Consultants

IRBᒤϦ࠻

IRB Office

5ԃ 5 years

2020.11.17

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