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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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 җΓᡏ၂ᡍہྗբำׇ 5.4ހᙯඤԋԜހҁǶ
This version was converted from “Version 5.4 of the SOP of the Human Research Committee.”
20141125
C 6 1.অׯ5.2.1่ਢൔЎҹኧໆǶ
1. The number of documents for the closing report was modified in item 5.2.1.
2. ஒচ5.3.1ڙ၂ޣᛝӕཀਜϐ၂ᡍᔠߕၗޑᇥܴ
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܍ᒤΓਡჹଌቩЎҹϐϣЎǶ
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.ᚒȐচᒦᒧቩہȑϷ5.4.1ǵ5.4.2ᒦ ᒧہϐϣЎǹཥቚ 5.4.3 ཥਢቩϷᅱ࿎ᆅำ
ׇǹ٠অׯ 5.1ࢬำკϐᡯϷ࣬ᜢЎҹǶ
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 5.5.3ቩวୃᚆǵӒϷڙ၂ޣғڮӼӄ܈ځд
ၴϸ၂ᡍউϐೀБԄǶ
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
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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. অׯ5.6.2ऩቩ่݀ࣁȨӕཀ่ਢȩޣϐೀࢬำǶ
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. চȨΓᡏ၂ᡍہȩ׳ӜࣁȨಃ/ΒΓᡏࣴزউ
ቩہȩǶ
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ቩཀـ߄嘹ׯࣁȨ่ਢਢҹቩख़ᗺݙཀ٣ᔠ 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. অׯ5.6.2ቩ่݀ǺচȨӕཀ่ਢȩׯࣁȨӕཀ่
ਢǴගεՉଓᇡ/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
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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 5.6.5ǺीฝЬΓӣᙟቩཀـϐ࣬ᜢೕۓǶ
6. Item 5.6.5 was revised regarding the procedure for the PI to respond to reviewers’ comments.
7. ཥቚ 5.7.3ε౻่݀ࣁȨόਡȩϐ࣬ᜢೕۓǶ
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،ۓቩБԄϷᒦᒧቩہȩ
ೢ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 ڙ၂ޣӕཀਜϷڙ၂ޣϭᒧҞႝηᔞ
܈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. ཥቚ5.2.5ՉёਜၸයЪຬၸ3ԃ҂ᛦҬଓᙫቩ
ൔਢҹϐೀᇥܴǶ
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
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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 5.4.1ᒦᒧቩہϐೢǺմନȐୋȑЬҺہ
Ƕ
Item 5.4.1 was revised regarding the responsible personnel for selecting reviewers: “(Vice) Chair”
was deleted.
4. অׯ 5.5.1ǺմନऩԖཀـǴளаќરᙄቪቩཀـǶ
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 ीฝਢϐቩᜪࠠǵ5.5.4.1 ቩϷ
5.5.4.2 ᙁܰቩϷΕ௨ำᇥܴǶ
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. অׯཥቚ5.6.1ᙯҬቩہཀـϐБԄǺཥቚႝηᔞǶ 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
6.9Ȩቩہᒦᒧ߄ȩϷ 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
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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 5.2.2.6ᇥܴϣȜऩࣁPTMS ҙፎਢ߾ሡ
ႝηᔞԿسջёǴคሡӑрરҁǹऩߚ PTMS ҙፎਢ߾ሡᔠߕ٠ϩးܭќҽၗ֨Ǵቩֹԋࡕ
߾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 5.3.3ऩीฝЬΓۘคݤගٮԋ݀ൔǴፎ୍
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 ፁғᅽճڄЎวЎВයȨ҇୯ 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 5.7.3౻่݀ȨਡȩਢҹǴऩࢂ่
݀ϝԖࡌǴ܍ᒤΓሡӃගٮቩ่݀ፎीฝЬ
ΓӣᙟቩཀـǴीฝЬΓӣᙟЎҹҗ܍ᒤΓഋ ଌȐୋȑЬҺہ/ՉઝਜਡёࡕǴ܍ᒤΓωё а໒ҥȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩǶ
20190527
2021.06.10
臺中榮民總醫院
參考文件
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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 ऩ౻่݀ࣁȨঅ҅ࡕਡȩǴीฝЬ
ΓံҹȐӣᙟቩཀـȑϺኧࣁ7ঁВϺǴऩຬၸ 14 ঁВϺ߾Չᄖਢǹܭӣᙟයज़ډයǴҙፎ ΓԖਸҗǴளਜय़ҙፎۯߏӣᙟයज़ 14 ঁВ
ϺǴаԛࣁচ߾Ƕຬၸӣᙟයज़Ъᔕਜय़ҙፎۯߏ ӣᙟයज़ϐਢҹǴஒӃഋଌՉઝਜǵȐୋȑЬҺہ
ץҢࢂցӕཀڙǶ܍ᒤΓഋଌȐୋȑЬҺہ
/ՉઝਜਡёࡕǴ܍ᒤΓωёа໒ҥȨΓᡏࣴز/
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
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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 5.7.3ϐဦࣁ5.7.5Ƕ
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 คરϯଌቩբǴঅׯᆶȨਜय़ၗȩ࣬
ᜢϐϣǶ
10. Process related to hardcopies was revised to comply with the new IRB policy of paperless submission.
20190527
G 14 1. ཥቚ߄ൂӜᆀǺȨPTMS่ਢൔቩཀـ߄ȩǶ
1. Document title was added: “PTMS Review Checklist for Closing Report.”
2. অׯ5.5.4.1 ቩϐቩ่݀Ƕ
2. Revised the review decision of Full Board Review in item 5.5.4.1.
3. অׯ5.5.4.2 ᙁܰቩϐቩ่݀Ƕ
3. Revised the review decision of Expedited Review in item 5.5.4.2.
4. অׯ5.6.3Ϸ5.7.4ϐीฝЬΓӣᙟයज़ࣁ28ঁВ
ϺǴ٠մନҙፎۯᇥܴЎӷǶ
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
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ुۓൂՏ
Composed by
ಃ/ΒΓᡏࣴزউቩہ
The First/Second IRB Committees
ᐒஏભ
Level of Confidentiality
Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ
Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO
ҔൂՏ
Applied to
ƑӄଣƑAll units in the hospital
ŶځдǴፎຏܴǺಃ/ΒΓᡏࣴزউቩہ
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
ɁᆅڋЎҹόளᏰԾ༡ׯϷဦ٠ЗቹӑǶ
ɁҁЎҹаKMسࣁനཥހҁǴરҁวՉሡSOPᆅύЈਡകǴᝄԾՉӈӑǶ
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.
ҁЎҹςೢЬᆅ҅ԄਡǴ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅύЈ
2021.06.10
臺中榮民總醫院
參考文件
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
่ਢቩᆅำׇਜ
SOP for Study Closure
ᒤൂՏ
Processing Unit
ቩཀـ
Review Comments
ᒤൂՏЬᆅ
Head of Processing Unit
คၠࣽቩሡǶ
There is no need for review by other departments or divisions.
ɈፎӚᒤൂՏЬᆅඁ፥ቩཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐǶ ɈThe head of each processing unit is advised to provide comments before signing/stamping to approve. If needed, it is recommended that the head of each processing unit discuss with the unit that made the SOP.
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
।ԛ
Page 1/14 ހԛ
Version G ހ 1.Ҟޑ
ࣁගٮӃ೯ၸቩϐीฝਢǴځ่ਢൔϐᛦҬǵଓᙫکቩբ
ё٩ൻϐೕጄǴुۓҁᆅำׇਜǶ 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
Ҕܭ၂ᡍीฝՉёਜډයǴЪ҂ҙፎۯߏ၂ᡍՉයज़Ǵ၀ी
ฝЬΓሡӵයᛦҬ่ਢൔϐीฝǶ 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.
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
Page 2/14 ހԛ
Version G ހ 5.բϣ
5. Procedure
5.1ीฝ่ਢቩᆅࢬำკ
5.1 Flow Chart of Study Closure Review
ࢬำ Flow Chart
ೢ
Responsible Personnel
࣬ᜢЎҹ Relevant Documents
Yes
অ҅ࡕᙚ Approval after
revision
ගፕ Send to full board
ਡ
Approval No
่ਢൔᛦҬ Submission of Closing Report
ଌቩЎҹዴᇡ Confirmation of
Submission
،ۓቩБԄ Ϸᒦᒧቩہ
Review Category &
Selection of Reviewers
ہቩ
Review
ीฝЬΓӣᙟ Response by PI
অ҅ࡕӆቩ Further review
after revision
εቩ
Board Meeting
่ਢ೯ޕ໒ҥϷਡഢ Issuance of Approval of
Study Closure
इᒵߥӸ Records Retention
অ҅
Revision
ᙚ Approval
ीฝЬΓ Principal Investigator
ीฝ่ਢൔ࣬ᜢ߄ൂ
Relevant forms for closing reports
܍ᒤΓ
Staff Members
่ਢൔ/ਢҹࢬำ߄ Closing reports/Protocol
Review Routing Form
Չਜ/
ȐୋȑЬҺہ
Executive Secretary/
(Vice) Chair
ଌቩЎҹ
Submission documents
ቩہ
Reviewers
่ਢၗ/PTMS่ਢൔቩཀـ߄ Study closure documents/
PTMS Review Checklist for Closing Report
ीฝЬΓ Principal Investigator
ಃ/ΒΓᡏࣴزউቩہ
ቩཀـӣᙟ߄ Form of Response to IRB
Reviewers’ Comments ہ
Reviewers
इᒵ Meeting Minutes
܍ᒤΓ/Չਜ/
ȐୋȑЬҺہ
Staff Members/ Executive Secretary/(Vice) Chair
ϦЎ/Γᡏࣴز/၂ᡍीฝ่ਢ೯ޕ Official Correspondence/
Approval of Clinical Trial Study Closure
܍ᒤΓ
Staff Members
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
।ԛ
Page 3/14 ހԛ
Version G ހ 5.2่ਢൔᛦҬ
5.2 Submission of Closing Report
5.2.1ीฝЬΓྗഢ่ਢൔЎҹǶ
5.2.1 The PI should submit the closing report.
5.2.2ीฝЬΓഢִ܌่ਢൔၗӵΠǺ
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 ่ਢൔ߄/ PTMS ่ਢҙፎਜȐҙፎΓሡᛝӜǴӵԖ
ԋ݀ൔፎߕȑǶ
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.)
5.2.2.3ҁՉёਜ/ଓᙫቩёਜ/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)
5.2.2.6Ȩڙ၂ޣӕཀਜȩϷڙ၂ޣϭᒧҞ।य़ႝηᔞ܈ቹҁ ȜཥހᔈߕҽֹޑȨڙ၂ޣӕཀਜȩቹҁǴځ дߕڙ၂ޣӕཀਜಃ1।ڙ၂ޣၗૻǵᛝӜ।ϷԖڙ၂ ޣϭᒧҞ।य़ϐቹҁջёȐቹӑȨڙ၂ޣӕཀਜȩਔǴ ሡाڙ၂ޣϭᒧҞޑϣाቹӑȑǶȨڙ၂ޣӕཀ ਜȩᕴҽኧեܭȐ֖ȑ30 ҽϐीฝਢǴӄኧᛦҬȨڙ
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
Page 4/14 ހԛ
Version G ހ ၂ޣᛝӕཀਜȩଌҁቩǹऩȨڙ၂ޣӕཀਜȩᕴ ҽኧεܭ 30 ҽϐीฝਢǴ٩ڙ၂ޣమൂϐȨӕཀਜȩ ᛝВයຯКٯȐڙ၂ޣᕴኧନа 30ȑܜрǴа 30 ҽࣁज़ǶಃΒԃ໒ۈϐଓᙫቩਢሡᛦҬཥԏਢ܈ཥ ᛝϐȨڙ၂ޣӕཀਜȩಃ1।ڙ၂ޣၗૻǵᛝӜ।Ϸ ڙ၂ޣϭᒧ।ቹҁǹऩࢂ҂યΕཥঁਢЪ҂Ԗཥᛝϐ Ȩڙ၂ޣӕཀਜȩǴሡᛦҬӄȨڙ၂ޣమൂȩջёȝǶ ȜऩࣁPTMSҙፎਢ߾ሡႝηᔞԿسջёǴค ሡӑрરҁǹऩߚPTMSҙፎਢ߾ሡᔠߕ٠ϩးܭќ
ҽၗ֨Ǵቩֹԋࡕ߾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
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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.
5.2.3ऩीฝЬΓ҂ܭёਜډයගрਏයۯϐҙፎǴᔈܭ
ёਜډයࡕΟঁДϣᛦҬȨ่ਢൔȩǴց߾ȐୋȑЬҺ ہԖ،ۓኩόڙځཥਢҙፎǶ
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.
5.2.4ଌҁቩϐीฝਢǴёਜϐԖਏයज़ၸයϤঁДࡕǴ҂
ଌȨ่ਢൔȩϒҁቩϐीฝЬΓǴኩόڙཥਢቩ
Ǵߩځ่ਢൔᛦҬࡕǴۈڙཥਢቩǶ
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.
5.2.5ՉёਜၸයЪຬၸ 3ԃ҂ᛦҬଓᙫቩൔϐਢҹǴ܍
ᒤΓளගεൔǴ٩ε،ೀࡕុ࣬ᜢ٣ەȐӵჴ ӦೖǵՉࡹ่ਢ٠ࡌЬΓௗڙ௲ػ૽ግ…،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܍ᒤΓਡჹȨଌቩЎҹȩǴନीฝ่ਢൔ߄/ PTMS ่ਢ
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
Page 6/14 ހԛ
Version G ހ ҙፎਜѦǴᔈᔠߕѸഢЎҹ˰ҁՉёਜ/ଓᙫቩё 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)˱.
5.3.2ၗሸӄࡕǴ܍ᒤΓڙҙፎᒤǶ
5.3.2 After compiling the submission documents, the staff member process the application.
5.3.3ऩीฝЬΓۘคݤගٮԋ݀ൔǴፎ୍ѸᔠߕᇥܴǶ
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،ۓቩБԄϷᒦᒧቩہ
5.4 Decision on Review Category and Selection of Reviewers
5.4.1চ߾ଌচቩہቩǴऩচቩہςߚҺہ܈ځ
дਸݩǴ߾җՉઝਜࡰࢴՏہжࣁቩǶ
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 ҂ԏਢϐ่ਢൔёҗՉਜǵȐୋȑЬҺہӕཀࡕǴ
ள٩ՉࡹำׇӃ๏ϒਡวȨΓᡏࣴز/၂ᡍीฝ่ਢ೯ޕȩϷ ϦЎ٠ܭεଓᇡǶ
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
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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.
5.4.3ȨཥਢȩऩቩำׇǴࡕុϐᅱ࿎ᆅȐջଓᙫቩǵ
অ҅ਢǵ่ਢ…ȑǴҭӕࣁቩำׇࣁϐȐ҇୯ 103 ԃ 07Д 28Вፁғᅽճፁᙴӷಃ1030120703 ဦڄȑǶ ϸϐǴऩᙁܰቩำׇǴ߾ࡕុᅱ࿎ᆅǴள௦Չᙁܰቩ
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.
5.5ہቩ
5.5 Review
5.5.1܍ᒤΓஒሸӄϐȨ่ਢၗȩଌہቩǶہᔈ٩ྣ၂
ᡍϐ୷ҁউচ߾ՉቩǴዴۓ၂ᡍϐՉ֡಄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.
5.5.2ࣴزीฝՉ่״ࡕǴہᔈዴᇡࣴزი໗ዴჴՉڙ၂ޣ
ᗦدϷёᒣၗᐒஏϐߥៈࡼǶ
5.5.2 The reviewer should evaluate if the PI and research
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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.
5.5.3ቩวୃᚆǵӒϷڙ၂ޣғڮӼӄ܈ځдၴϸ၂ᡍউ
ǴҥջೀޣǴёፎȐୋȑЬҺہє໒ᖏਔǹߚ ᆙ࡚ݩǴёाीฝЬΓܭΠԛεਔډᇥܴǴѸ
ाਔӼ௨ჴӦೖǶ
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.
5.5.4ीฝਢϐቩᜪࠠࣁቩϷᙁܰቩǶ
5.5.4 The review category of the protocol may be full board or expedited review.
5.5.4.1 ቩ
5.5.4.1 Full Board Review
a.ऩቩ่݀ࣁȨࡌ೯ၸȩЪόሡӣᙟϐीฝǴ߾ޔௗ
௨Εന߈ԛεำਡഢǶ
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.ځہቩޑ่݀ࣁȨࡌঅ҅܈ගٮᇥܴȩǴ
ीฝЬΓᔈܭज़යϣӣᙟቩཀـǴ܍ᒤΓ༼ၗ
ࡕஒ၀ਢҹևଌΕץҢൂϒՉਜǵȐୋȑЬҺ ہቩਡǴऩቩਡޑ่݀ࣁȨӕཀ௨Εന߈ԛޑε
ਡഢȩǴ߾ޔௗ௨Εന߈ԛεਡഢǶ
b. If the review decision is “recommended for revision or
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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.ځہቩޑ่݀ࣁȨࡌό೯ၸ)ගፕ*ȩǴीฝ ЬΓᔈܭज़යϣӣᙟቩཀـǴ܍ᒤΓ༼ၗࡕ ௨Εന߈ԛεำፕǶ
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 ᙁܰቩ
5.5.4.2 Expedited Review
a.ځہޑቩ่݀ऩࣁȨࡌঅ҅܈ගٮᇥܴȩǴ
ीฝЬΓᔈܭज़යϣӣᙟቩཀـϷᔠଌ׳҅ߕҹǴ ऩቩཀـຏܴȨঅ҅ࡕӆቩȩǴ܍ᒤΓӆஒीฝЬ
ΓϐӣᙟཀـᙯፎቩہӆԛຑਡǶ
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.ځہޑቩ่݀ऩࣁȨό಄ӝᙁܰቩǴׯଌቩ
ȩǴीฝЬΓᔈܭज़යϣӣᙟቩཀـǴ܍ᒤΓ
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
Page 10/14 ހԛ
Version G ހ
༼ၗࡕ௨Εന߈ԛεำፕǶ
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.ځہޑቩ่݀ऩࣁȨ೯ၸȩЪόሡीฝЬΓӣᙟ ϐीฝǴ߾܍ᒤΓᔈӃஒ၀ਢҹևଌՉਜǵȐୋȑ ЬҺہቩਡࡕਡวёਜ٠ගԿεଓᇡǶ
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.
5.6ीฝЬΓӣᙟ
5.6 The PI’s Response to Reviewers’ Comments
5.6.1ቩہԖཀـਔǴ܍ᒤΓᔈᗦѐቩޣۉӜ٠ஒཀـ
ϣаႝηᔞҬଌीฝЬΓǴፎځӣᙟǶ
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.ӣᙟہቩཀـϐਢҹǴीฝЬΓܭज़යϣӣᙟቩ
ཀـࡕǴ܍ᒤΓᔈӃஒ၀ӣᙟևଌՉਜǵȐୋȑЬҺ ہቩਡǴаዴᇡࢂցё௨Εന߈ԛයਡഢ܈ሡගԿε
ፕǶ
5.6.2 If the review requires the PI to submit response to reviewers’ comments, then the PI should give response by
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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.
5.6.3ቩཀـ೯ޕीฝЬΓࡕሡܭ7ঁВϺӣᙟǴऩຬၸ28
ঁВϺϝ҂ӣᙟ߾ՉᄖਢǶ
5.6.3 The PI should respond to reviewers’ comments within 7 calendar days. If the PI does not respond within 28 days, the protocol should be withdrawn from IRB consideration.
5.7εቩ
5.7 IRB Board Meeting
5.7.1ہᔈቩӦፕϷቩȨ่ਢൔȩǶ
5.7.1 IRB members should thoroughly discuss and review closing reports.
5.7.2ፕࡕǴऩคҺՖہԖ౦Ǵ߾ϒаਡഢǶ
5.7.2 Study closure is approved when all members come to a consensus to approve it after discussion.
5.7.3౻่݀ȨਡȩਢҹǴऩࢂ่݀ϝԖࡌǴ܍ᒤ
ΓሡӃගٮቩ่݀ፎीฝЬΓӣᙟቩཀـǴीฝЬ
ΓӣᙟЎҹҗ܍ᒤΓഋଌȐୋȑЬҺہ/Չઝਜਡё ࡕǴ܍ᒤΓωёа໒ҥȨΓᡏࣴز/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 ऩ౻่݀ࣁȨঅ҅ࡕਡȩǴीฝЬΓံҹȐӣᙟቩ
ཀـȑϺኧࣁ7ঁВϺǴऩຬၸ28ঁВϺϝ҂ӣᙟ߾
ՉᄖਢǶ܍ᒤΓഋଌȐୋȑЬҺہ/ՉઝਜਡёࡕǴ܍
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ SOP for Study Closure
Page 12/14 ހԛ
Version G ހ ᒤΓωёа໒ҥȨΓᡏࣴز/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 ऩε౻่݀ࣁȨόਡȩǴ߾٩εߕ،ȐӵǺჴ
Ӧೖȑᒤࡕុ࣬ᜢ٣ەǶ
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
่ਢൔቩӕཀࡕǴ܍ᒤΓഋଌՉਜǵȐୋȑЬҺہ
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܍ᒤΓё໒ҥȨΓᡏࣴز/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
࣬ᜢΓᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚइᒵǶ 5.10 Records Retention
Relevant personnel should keep all records carefully following the guidelines below.
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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
่ਢൔ߄/ 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
ಃ/ΒΓᡏࣴزউቩہ่ਢൔ
ਢҹቩख़ᗺݙཀ٣ᔠਡ߄/PTMS
่ਢൔቩཀـ߄
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
ಃ/ΒΓᡏࣴزউቩہቩཀ 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 ቩہᒦᒧ߄
Reviewers Selection Form
IRBᔞਢ࠻
IRB Archive
၂ᡍ่״ࡕ3ԃ At least 3 years after
the trial is closed
6.ߕҹ
ȨPTMS่ਢҙፎਜȩǵȨPTMS่ਢൔቩཀـ߄ȩǵȨϦЎȩࣁ
ጕسᒡΕǴคހҁᇤҔϐဤǴࡺόӈΕߕҹᆅǶ 6. Appendices
“PTMS Study Closure Application Form”, “PTMS Review
2021.06.10
臺中榮民總醫院
參考文件
Ўҹጓဦ
Document Number
IRB-ҁ-πբதೕ-2013
IRB -Regulations of Operation-2013
Ўҹ Ӝᆀ
Title
่ਢቩᆅำׇਜ 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 6.2่ਢൔ߄
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 ಃ/ΒΓᡏࣴزউቩہ่ਢൔਢҹቩख़ᗺݙཀ٣
ᔠਡ߄
6.5 IRB Review Checklist for Closing Report
6.6ಃ/ΒΓᡏࣴزউቩہቩཀـӣᙟ߄ 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 6.9ቩہᒦᒧ߄
6.9 Reviewers Selection Form
2021.06.10
臺中榮民總醫院
參考文件