ҁЎҹς࿶៾ೢЬᆅ҅Ԅਡ঑Ǵ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅ౛ύЈ

(1)

ु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 5 ཥुǶNewly composed. 20140519 B 5 җΓᡏ၂ᡍہ঩཮኱ྗբ཰ำׇ5.4 ހᙯඤԋԜހҁǶ

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

20150119

C 5 চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋/ΒΓᡏࣴزউ౛ቩ

ࢗہ঩཮ȩǶ

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

20160318

D 5 অׯୖԵЎҹ3.2ȨΓᡏ၂ᡍᆅ౛ᒤݤȩހҁǶ

The version of “Regulations on Human Trials” was updated in reference item 3.2.

20170709 D 10 ٩ҁଣೕۓǴܭ 2019ԃ 05 Д17 Вख़ཥቩຎҁЎҹǴ

ϣ৒ค໪অׯǶ

According to the regulations by TCVGH, this document was reviewed again on 17 May 2019 and no revision was needed.

20170709

E 10 অׯୖԵЎҹ3.1 ࣁȨᛰࠔᓬؼᖏ׉၂ᡍբ཰ྗ߾ȩȐ109 ԃ08 Д28 Вঅ҅ȑǶ

Updated reference 3.1 into “the Regulations for Good Clinical Practice (amended on 28 August 2020).”

20210528

ुঅቲ

Composed/Revised/Deleted

ቩਡ

Reviewed

ਡ঑

Approved

ɁᆅڋЎҹόளᏰԾ༡ׯϷ଺૶ဦ٠࿣ЗቹӑǶ

ɁҁЎҹаKMس಍ࣁനཥހҁǴરҁวՉሡ࿶SOPᆅ౛ύЈਡകǴᝄ࿣ԾՉӈӑǶ

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.

ҁЎҹς࿶៾ೢЬᆅ҅Ԅਡ঑Ǵ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅ౛ύЈ

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臺中榮民總醫院

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཮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

Ɉ

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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1.Ҟޑ

ҁᆅ౛ำׇਜࣁᆅ౛ǵ໺ଌϷᆢៈςҗಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ

঩཮ቩࢗ೯ၸޑीฝᔞਢϷ࣬ᜢЎҹǶჹܭӵՖӼӄߥஏӦӸܫǵፓ

᎙ǵቹӑаϷ࣬ᜢЎҹᎍ྄ගٮࡰЇǶ 1. Purpose

The purpose of this SOP is to provide guidelines for managing, distributing, and maintaining documents related to protocols approved by the IRB. The SOP also gives instructions for document retention, viewing and copying, and for destruction of copies.

2.፾Ҕጄൎ

ҁᆅ౛ำׇਜ፾Ҕܭ܌Ԗҗಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ᒤϦ࠻

܌ᆢៈϐीฝᔞਢϷ࣬ᜢЎҹǶ 2. Scope

This SOP applies to all protocol records and related documents retained and maintained by the IRB.

3.ୖԵЎҹ 3. References

3.1Ȩᛰࠔᓬؼᖏ׉၂ᡍբ཰ྗ߾ȩȐ109ԃ08 Д28Вঅ҅ȑȐಃ 29 చೕۓǺȨΓᡏ၂ᡍہ঩཮ᔈߥӸਜय़բ཰ำׇǵہ঩Ӝൂǵہ

঩ᙍ཰ϷᖄᛠӜൂǵଌቩЎҹǵ཮᝼इᒵǵߞҹǵϷځдᖏ׉၂ ᡍ࣬ᜢၗ਑Կ၂ᡍ่״ࡕΟԃǴЪёٮЬᆅᐒᜢᒿਔፓ᎙Ƕȩȑ 3.1 According to Article 29 of the Regulations for Good Clinical

Practice (amended on 28 August 2020), “The Ethics Committee should retain written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, correspondence and any other relevant records for a period of at least 3 years after completion of the trial and make them available upon request

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from the Competent Authority.”

3.2ȨΓᡏ၂ᡍᆅ౛ᒤݤȩȐ҇୯105ԃ 04Д 14Вፁғᅽճ೽ፁ೽

ᙴӷಃ1051662154ဦзঅ҅วѲȑಃ 10 చೕۓǺȨቩࢗ཮ᔈ

ஒΓᡏ၂ᡍीฝǵ཮᝼इᒵǵࢗਡइᒵ฻࣬ᜢЎҹǴߥӸԿΓᡏ ၂ᡍֹԋࡕԿϿΟԃȩǶ!

3.2 According to Article 10 of the Regulations on Human Trials (amended on 14 April 2016 and promulgated by the Ministry of Health and Welfare, pursuant to Wei-Bu-Yi-Zi No.

1051662154), “The Review Board shall preserve the relevant documentation, such as Human Trial proposal, meeting minutes, or audit records for at least three(3) years after the completion of Human Trial.”

4.Ӝຒۓက 4. Definitions

4.1ᔞਢЎҹ 4.1 Documents

ᔞਢЎҹхࡴՠόज़ܭΠӈӚ໨ǴёаࢂҺՖ׎ԄǴӵӈӑ܈ਜ ቪޑરҁǵቹӑҁǵႝηແҹǵ໺੿ǵቹॣइᒵᔞਢ܈ႝηЎҹ ᔞ฻Ƕ

Documents may include but are not limited to the following items, and may be in any format: printed or written copies, photocopies, e-mail, fax, video or audio recordings, electronic files, etc.

4.1.1ीฝਜϷ࣬ᜢЎҹȐӵঁਢൔ֋߄ǵڙ၂ޣӕཀਜǵВᇞ߄ǵ

ࣽᏢ܄Ўҹǵൔ֋ǵइᒵǵ஑ৎཀـ܈ቩࢗຑፕȑǶ

4.1.1 Protocols and related files (e.g. case reports, ICF, daily journal, scientific documents, reports, records, comments by expert consultants or reviewers).

4.1.2ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ЎҹȐ኱ྗϯЎҹǵ཮᝼૶

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ᒵǵࡌ᝼Ϸ،᝼ȑǶ

4.1.2 Documents related to the First/Second IRB Committees (standardized documents, meetings minutes, recommendations and resolutions).

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5. բ཰ϣ৒

5. Procedure

5.1ᔞਢᆢៈᆅ౛ࢬำკ

5.1 Flow Chart of Document Management

ࢬำ Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ Relevant Documents ڙ౛ӚᜪीฝϷᔞਢ

Acceptance of applications and documents

ख़ፄЎҹᘜᗋ Return of duplicate

documents

ᔞਢᓯӸϷٛៈ

Document retention and maintenance

ᔞਢॷ᎙Ϸቹӑ Request for viewing or

copying documents

ၸයᔞਢᎍ྄

Destruction of expired documents

इᒵߥӸ Records retention

܍ᒤΓ঩

Staff Members

ीฝమн/IRB஑ਢᆅ౛س಍

/PTMSس಍

List of protocols/IRB project management system/PTMS

system

܍ᒤΓ঩

Staff Members

ख़ፄЎҹ Duplicate documents

܍ᒤΓ঩

Staff Members

ᔞਢ࠻Γ঩຾рᆅڋ߄ Personnel control record for

IRB Archive

܍ᒤΓ঩

Staff Members

Ўҹፓ᎙߄/Ўҹቹӑҙፎ߄ Application for

documents/Application for copying documents

܍ᒤΓ঩

Staff Members

ᎍ྄మн

List of destroyed documents

܍ᒤΓ঩

Staff Members

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5.2ڙ౛ӚᜪीฝϷᔞਢ

5.2 Acceptance of applications and documents

܍ᒤΓ঩ܭڙ౛ӚᜪीฝϷᔞਢࡕǴᔈ٩ᏵӚ໨ቩࢗᆅ౛ำׇਜ ϐೕۓǴᔠࢗځֹ᏾܄Ǵዴᇡคᇤࡕஒ࣬ᜢၗ਑ฦᒵܭӚᜪȨी

ฝమнȩǵȨIRB஑ਢᆅ౛س಍ȩǵȨPTMSس಍ȩ฻Ƕ

The staff member should verify that submitted documents are complete and accurate when receiving applications. If the applications are confirmed to be complete and accurate, the staff member should then record the documents in relevant list of protocols, IRB project management system, or PTMS system.

5.2.1ཥीฝǶ 5.2.1 New protocol.

5.2.2ቩࢗύीฝǶ

5.2.2 Protocol under review.

5.2.3୺ՉύीฝǶ 5.2.3 Study in progress.

5.2.4ς่ਢϐीฝǶ 5.2.4 Closed study

5.2.5ӚᜪՉࡹЎҹǴӵہ঩཮཮᝼इᒵǵہ঩Ӝൂ…฻Ƕ

5.2.5 Administrative documents, e.g. IRB meeting minutes, list of IRB members….

5.3ख़ፄЎҹᘜᗋ

5.3 Return of duplicate documents

܍ᒤΓ঩ܭௗڙӚᜪीฝϷᔞਢਔǴऩว౜ख़ፄЎҹǴଏӣीฝ Ь࡭ΓǶ

If the staff member discovers duplicate documents when reviewing applications and submitted documents, the

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duplicates should be returned to the PI.

5.4ᔞਢᓯӸϷٛៈ

5.4 Document retention and maintenance

܍ᒤΓ঩ᔈୖྣӵΠϐೕጄǴ຾ՉᔞਢᓯӸϷٛៈǶ

The staff member should retain and maintain documents following the guidelines below.

5.4.1ஒځд࣬ᜢՉࡹЎҹ࿼Εӝ፾ޑᔞਢᘕߥᆅᓯӸǶ

5.4.1 Related administrative documents should be stored in appropriate file cabinets.

5.4.2ᔞਢ࠻ᔈ຾ՉѸाϐߐ࿣ᆅڋǴᝄ࿣πբΓ঩аѦϐΓ঩຾

рǴπբΓ঩຾рਔ໪༤ቪȨᔞਢ࠻Γ঩຾рᆅڋ߄ȩǶ 5.4.2 Access to the archive should be monitored and controlled.

No personnel should be allowed to enter the IRB Archive except staff members. Staff members should fill in the form of “Personnel Control Record for IRB Archive” while entering or exiting the IRB Archive.

5.4.3ᔞਢ࠻ᔈ೛࿼፾྽ϐ੃ٛ೛ࡼǶ

5.4.3 The Archive should be equipped with a fire detection and fire protection system.

5.4.4ऩࣁႝηᔞǴ߾ᔈҗس಍೛ۓ྽ၗ਑Ԗ౦୏ਔس಍Ծ୏ഢҽ

Կ໦ᆄၗ਑৤Ǵ٠೛ۓ஦ဦஏዸа຾ՉᆅڋǶ

5.4.4 Electronic files should be set to back up automatically in a cloud database every time a file is modified. Accounts and passwords should be set to control access to the files.

5.5ᔞਢॷ᎙Ϸቹӑ

5.5 Request for viewing or copying documents 5.5.1ᔞਢॷ᎙

5.5.1 Request for viewing documents

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5.5.1.1 ہ঩ǵቩࢗہ঩ǵीฝЬ࡭ΓऩԖॷ᎙ᔞਢϐሡ؃ਔǴ ᔈ༤ቪȨЎҹፓ᎙߄ȩǴЪ໻ज़ܭፓ᎙ځࣴزीฝϐ࣬ᜢ

ၗ਑Ǵ࿶ȐୋȑЬҺہ঩ਡ঑ࡕǴБёፓ᎙Ƕ

5.5.1.1 IRB members, reviewers, or PI may request to view IRB documents if needed by filling in the “Application for Viewing Documents.” Only documents related to relevant protocols may be requested for viewing after the approval of the (Vice) Chair.

5.5.1.2 ܍ᒤΓ঩ᔈ٩ᏵȨЎҹፓ᎙߄ȩ܌ӈϐЎҹǴפр໪ፓ

᎙ЎҹϐᓯӸՏ࿼Ǵڗрፓ᎙ЎҹǴ٠ܭȨЎҹፓ᎙߄ȩ

΢ᛝӜکᛝຏВයǶ

5.5.1.2 The staff member should find the storage location and retrieve the documents listed on the “Application for Viewing Documents,” and sign and date the

“Application for Viewing Documents.”

5.5.1.3 ܍ᒤΓ঩ᔈा؃ፓ᎙Γܭҁہ঩཮ᒤϦ࠻ϣࢗ᎙Ǵ٠ό

ளҔҺՖБԄԾՉፄᇙǴ᎙౥ࡕ໪ஒፓ᎙Ўҹֹ᏾ᘜᗋ

܍ᒤΓ঩Ƕ

5.5.1.3 The staff member should require the person requesting to view the documents to view the documents in the IRB Office. No photocopies or duplicates should be made in any format during the viewing. The documents should be returned to the staff member after viewing.

5.5.1.4 ᘜᔞϐ܍ᒤΓ঩ஒፓ᎙ЎҹᘜӣᔞਢᘕࡕǴᔈӧЎҹፓ

᎙߄΢ᛝӜکᛝຏВයǴ٠ஒ၀ᔞਢᘕ΢ᙹǶ

5.5.1.4 After the documents are returned to the staff member, the staff member should put the documents back to the original file cabinets, sign and date the “Application for Viewing Documents,” and lock the file cabinets.

5.5.1.5 ऩԖځд੝ਸፓ᎙ሡ؃ਔǴ໪а஑ਢ஑ᛝ࿶ЬҺہ঩ਡ

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Ңᒤ౛Ƕ

5.5.1.5 If a special request is made to view documents, the request should be processed on a case-by-case basis following the instructions of the Chair.

5.5.2ᔞਢቹӑ

5.5.2 Request for copying documents

5.5.2.1 ЎҹޑቹӑҁǴхࡴ߃ዺکࡕុঅ҅ޑހҁǴ֡ຎࣁᐒ

ஏԶόளϦ໒Ƕ

5.5.2.1 Photocopies of documents, including first drafts and follow-up amended versions, should be handled as classified documents and should not be disclosed to the public.

5.5.2.2 ीฝЬ࡭ΓऩԖቹӑЎҹϐሡ؃ਔǴᔈ༤ቪȨЎҹቹӑ

ҙፎ߄ȩǴЪ໻ज़ܭځࣴزीฝϐ࣬ᜢၗ਑Ǵ࿶Ȑୋȑ ЬҺہ঩ਡ঑ࡕǴБёቹӑǶ

5.5.2.2 The PI may request to copy documents if needed. An

“Application for Copying Documents” should be filled in and submitted. Only documents related to the study conducted by the PI may be requested to be copied with the approval of the (Vice) Chair.

5.5.2.3 ܍ᒤΓ঩ᔈ٩ᏵȨЎҹቹӑҙፎ߄ȩ܌ӈϐЎҹǴפр

໪ቹӑЎҹϐᓯӸՏ࿼ǴڗрЎҹǴ٠ܭȨЎҹቹӑҙ ፎ߄ȩ΢ᛝӜکᛝຏВයǶ

5.5.2.3 The staff member should find the storage location and retrieve the documents listed on the “Application for Copying Documents,” and sign and date the

“Application for Copying Documents.”

5.5.2.4࿶ȐୋȑЬҺہ঩ࡰۓϐቩࢗہ঩Ԗ៾ा؃ቹӑҁǶ

5.5.2.4 Reviewers assigned by the (Vice) Chair may request copies of documents.

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5.5.2.5܍ᒤΓ঩Ԗ៾຾ՉቹӑǶ

5.5.2.5 The staff members are authorized to photocopy documents.

5.5.2.6 ऩԖځд੝ਸቹӑሡ؃ਔǴ໪а஑ਢ஑ᛝ࿶ЬҺہ঩ਡ

Ңᒤ౛Ƕ

5.5.2.6 If a special request is made to photocopy documents, the request should be processed on a case-by-case basis following the instructions of the Chair.

5.5.3܍ᒤΓ঩ᔈஒҙፎΓϐȨЎҹፓ᎙߄ȩϷȨЎҹቹӑҙፎ߄ȩ

ቹӑ΋ҽܫ࿼ܭځ܌ࢗ᎙Ўҹϐᔞਢၗ਑֨ύǴаᕕှ၀ᔞ ਢ೏ॷ᎙Ϸቹӑ௃׎Ƕ

5.5.3 The staff member should make a photocopy of the

“Application for Viewing Documents” and the “Application for Copying Documents” and place the photocopy in the folder of each requested document in order to keep a record of the documents being viewed or copied.

5.6ၸයᔞਢᎍ྄

5.6 Destruction of expired documents

ჹܭຬၸߥᆅԃज़ϐЎҹǴ܍ᒤΓ঩ளගрၸයЎҹᎍ྄ҙፎբ

཰Ǵ࿶ںਡࡕ୺Չᎍ྄Ƕ

The staff member may propose to destroy documents which have passed the time limit for records retention. The expired documents may be destroyed after being approved by the staff member’s supervisor.

5.7इᒵߥӸ

5.7 Records Retention

࣬ᜢΓ঩ᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚ໨इᒵǶ

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

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ጓဦ No.

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period 1

ᔞਢ࠻Γ঩຾рᆅڋ߄

Personnel Control Record for IRB Archive

IRBᔞਢ࠻

IRB Archive

3ԃ 3 years

2 Ўҹፓ᎙߄

Application for Viewing Documents

IRBᒤϦ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years

after the trial is closed

3 Ўҹቹӑҙፎ߄

Application for Copying Documents

IRBᒤϦ࠻

IRB Archive

၂ᡍ่״ࡕ3ԃ At least 3 years

after the trial is closed

6.ߕҹ

6. Appendices

6.1ᔞਢ࠻Γ঩຾рᆅڋ߄

6.1 Personnel Control Record for IRB Archive 6.2Ўҹፓ᎙߄

6.2 Application for Viewing Documents 6.3Ўҹቹӑҙፎ߄

6.3 Application for Copying Documents

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