5/22 工作交接表

由於較完整的檔案太大,故先暫時放上此圖.

5/18 中國醫藥大學 IRB

回覆孟醫師的問題:
1. 計畫書中之「試驗計畫編號（頁面23）」，應該是指：如果試驗計畫書有任何修正，必須有修正編號及日期。因為我手上並沒有計畫的副本，不知道該如何填寫，煩請謝教授提供此修正編號，以及日期。
#試驗計畫編號是以自己方便記憶來填寫；若初審未通過，則試驗主持人補送相關資料再送審，這時候才需有修正編號以及日期，以利於分辨此計劃為第二次修改。因此本次計劃編號將設為CMUHRversion1，重審後計劃編號須改變為CMUHRversion2(R代表rehabilitation)。若您有其他方便記憶的計畫編號，是可以更改的。

2. 請謝教授提供經費預算表，謝謝。
#已將經費預算表附上。

3. 表格中「協同主持人」資料之諸多欄位，是否填入謝教授的個人資料？煩請教授協助填入。另外，IRB文件中協同主持人之學經歷表格，也須於送件前完成。由於此文件仍需簽名，不知道如何迅速順利完成？
#由於謝教授目前尚在安排上藥品優良臨床試驗規範（GCP）和醫學倫理訓練的課程，故無法擔任此計劃之協同主持人。

5/20 修改 工作交接清單

2008年5月結束 工作交接清單
#交接的對象
#分數登錄檔案的名稱

1.ADL & BIB item bank 資料彙整(佳苓)
-校對資料
-馬偕醫院和亞東醫院之個案資料彙整

2.PEP-3 資料彙整
-檔案資料的名稱
-其他注意事項

3.Stream-CAT
-PDA的使用性(阿凱)
-(追蹤/收集榮總治療師之帳號以及密碼設定)

4.榮總醫院職能治療之生理組-ADL , BIB item bank ,中風個案健康問卷& Stream-CAT之後續追蹤
-他們對評估工具之熟悉度或者問題(佳苓)

5.FDT評估工具之後續追蹤
-信件回覆(說明要將FDT修改為中文版本)
-FDT評估手冊-交由豪介公司負責詢問

6.萬芳醫院評估之後續安排(提醒老師)

7.將電腦資料拷貝下來(玉雲姐)
8.其它

-----------------------------------------------------------------------------
榮總醫院對ADL item bank 以及 中風個案健康層面問卷的相關問題
1.在IADL的部份,沒有提及從事頻率的評分標準?我們應該從何根據加於給分?
ANS:評量層面：評估個案平時從事該活動的實際表現，而非執行能力。
訪談方式：先確認個案平時「有沒有做」，再掌握「如何做」，然據以評分
2.在此健康層面問卷中,是否以其功能改變的項目評估?在於正/負情緒的項目,如何評分?
ANS:標題(變化)修正為狀況,如果其功能沒有受到影響,就無須繼續評重要性!
至於正/負情緒就將正面情緒刪除.

2008/5/19 工作交接清單 (草稿)

2008年5月結束 工作交接清單

1.ADL & BIB item bank 資料彙整
2.PEP-3 資料彙整
3.Stream-CAT (追蹤/收集榮總治療師之帳號以及密碼設定)
4.榮總醫院職能治療之生理組-ADL , BIB item bank ,中風個案健康問卷& Stream-CAT之後續追蹤
-他們對評估工具之熟悉度或者問題
5.馬偕醫院和亞東醫院之個案資料彙整
6.FDT評估工具之後續追蹤
7.萬芳醫院評估之 後續安排
8.其它

4/8 asessment & narration of ADL&QOL

Mission:
1.The narration of ADL& QOL :
a. Mention out the main difference criteria between this two questionaires, so that the reader easy to understand and recognize it.


2.Figure out the interval time of latest PEP-R & PEP.

4/7 asessment & narration of ADL&QOL

Mission:
1.Calling TVGH rehabilitation center occupational therapist 顏老師,and make an appointment with them for explanation of ADL item bank and QOL questionaire.
2.The narration of ADL& QOL :
a. The arrangement of ideas:
1 .princles. 2.The general awareness of questionaire.
b. The writing of paragragh:
1.No need too polite and conventional verbal exchanges or informal sentencees.
2.Recheck each sentencees to figure out isn't there have any relation sentences.

4/3 asessment & narration of ADL&QOL

Mission:
1.I've finished about 4 of each BIB &ADL.
2.Have to wrting a letter for the author of FDT, that need to mention about we will try the FDT in our research and need to change some details on the chinese version.
3.Narration of ADL&QOL:
a. The main idea of ADL item bank didn't explain clearly and show the unique of the item bank.Why we need to make this item bank?
b. The main idea of QOL questionaire also need to re-arrangge the structure of sentencees.

4/2 PEP-3 & narration

Mission:
1.PEP-3
a.6raters from 3difference work place(NTUH's therapist,MHH's therapist and research assisstant).How to random between this 6people.

4/1 asessment & narration of ADL&QOL

Mission:
1. Amending the narration of ADL & QOL.
a.arrangement of ideas are not suitable.
b.procedure are not completely
c.adding the main idea of each questionaires

2.PEP-3 interrater reliability:
we consider out three kinds design:
a.three raters :2 observers,1 raters
not enough employee for the test.
b.two raters: 1 raters,1 observer
couldn't observe the diference between two raters
c.two raters: Random out one rater between two raters
Seem this design is suitable to our condition now!

3/31 assessment

Mission:
Answering the questions about the design of interrater reliability.
「施測者間信度」為不同施測者對相同對象施測所得結果的一致性，用以檢驗工具的評量結果是否受到施測者的主觀判斷影響。
1.Find out the advantage and disadvantage points?
代表性,可行性,有價值-->>basic point

2.Does this study design suitable with the clinical environment?
Ans:The number of the clinical therapists still need to complement, so the PEP-3 assessment couldn't have more than one rater(therapist) to take in.
The time spent to assess PEP-3 with 2 Raters comparing with one raters were almost similarly(about 30minutes), but may be related to the function level of the child.

3.Asking the clinicals T's about the efficiency of the study design?
Ans:Only one rater assess the examination will be suitable for clinical.

4.Find out the source's influence of the result?
Ans:T's experience,attitude and instructions will be the main influence of the result.

Other Q:
1.Find out the basic rule of different kinds interrater-reliability?
2.Writing out the inclusion and exclusion criteria?

3/28 assessment

Mission:
1.This week I've finished 10 ADL and BIB.
2.Remember to find Stroke OPD pateints for the testing of QOL.
3.Preparing the paper for explaining the content of ADL and QOL.

3/27 inter-rater reliability design

Mission:

1.find out the meaning of inter-rater reliability?
inter-rater reliability is the degree of agreement among raters. It gives a score of how much homogeneity, or consensus, there is in the ratings given by judges. It is useful in refining the tools given to human judges, for example by determining if a particular scale is appropriate for measuring a particular variable. If various raters do not agree, either the scale is defective or the raters need to be re-trained.

There are a number of statistics which can be used to determine inter-rater reliability. Different statistics are appropriate for different types of measurement. Some options are: joint-probability of agreement, Cohen's kappa and the related Fleiss' kappa, inter-rater correlation, concordance correlation coefficient and intra-class correlation.

2.Find out the advantage and disadvantage points?

3.Does this study design suitable with the clinical environment?

4.Asking the clinicals T's about the efficiency of the study design?
Only one rater assess the examination will be suitable for clinical.

5.Find out the source's influence of the result?
T's experience,attitude and instructions will be the main influence of the result.

3/26 Inter-rater reliability study design

Mission:

1.Learning to design an inter-rater reliability for PEP-3,we have find out 3 kinds of idea.one examinaiton need 30minutes ~1 hours for 2~3times, that will have another examination between 1 weeks.
a.three raters-one assess, the other two raters as an observer.
b.the first time is A rater, the second time is B Rater.
c.Only A rater assess,B rater as an observer.
The First idea needs more raters, more times, more efforts,learning effect and different instruction between two raters in examination.

Conclusion:
1.find out the meaning of inter-rater reliability?
2.Find out the advantage and disadvantage points?
3.Does this study design suitable with the clinical environment.
4.Asking the clinicals T's about the efficiency of the study design?
5.Find out the source's influence of the result?

3/25 PEP-3 assessment and correct the pictures

Mission:
1.Searching and finding the suitable pictures for the picture book ,for example Kiddie cab,holding dog and chicken or hen .That is because there(western and eastern) have culture different in some matter.
2.I'm using Photoimpact to correct the pictures, and the pictures need about 500*500 only it will looking clearly.

3/24 Assessment

Mission:
1.Today i have finished about 3 BIB & ADL,another is QOL.

3/21 Manuel Sedo's letter &ADL,BIB assessment

Mission:
1.I had receive the letter of the FDT's author Manuel sedo.
a. Does the FDT have the Mandarin version, if so how could I get it? Does the Mandarin version have any copyright? Ans:He had sent the chinese version for us and he also very interesting in our research.
b. On the contrary, if doesn’t have the Mandarin version of the FDT, does it need an authorized translation if we would like to translate the FDT to Mandarin?The chinese version that he gave us still not yet have authorized translation.

2.Today i have assessment about 2 BIB and ADL item banks.This week i have finished 1PEP-3,2QOL han and 1ADL &BIB.

3/19 IRB,QOL &PEP-3

Mission:
1.correcting IRB of <中風病人肢體動作量表及行走速度測驗之最小重要差異值>.
審查意見：
A. 受試者同意書第三項納入排除條件：請依照自評表Ⅱ通則修改，「受試者」、「病人」以「您」取
代，e.g.「您符合…，適合參加研究。」。
B. 「計劃」應為「計畫」，請修改。
C. 受試者同意書中的英文名詞，請加註中文名稱，e.g.「MMSE」、「VAS」等。

2.I have finished 1 QOL and PEP-3.


臨床試驗案 200803009R 新案申請 快審專家審查意見 如附檔。
臨床試驗案 200803009R，為 快審純學術 多中心 案件，由 台大醫學院職能治療學系 謝清麟教授 提出申請。

請針對專家意見修改，備妥下列資料送至台大醫院北棟(A、B)地下4樓 研究倫理委員會。
● 紙本資料1份，排列方式如下：
◎下述之資料，請準備正本1份。
1. 回覆專家意見說明
(請針對專家意見，回覆在對應的格子內，首頁空白處需有主持人簽章，並加註日期)
2. 修改後之資料一份
(只需附上修正後的資料，並請用螢光筆標示修正處以便審查，若有修改計畫書或受試者同意書，請主持人在首頁空白處簽章，並加註日期）
● 電子檔案1份，編碼方式如下：
1. 回覆意見–版本日期
2. 申請書(版本日期)–修正前(ex: Protocol-version2(Mar122007)-修正前)
3. 申請書(版本日期)–修正後(如果有修改，請用不同顏色的字體標示修正處)
4. 計畫書(版本日期)–修正前(ex: Protocol-version2(Mar122007)-修正前)
5. 計畫書(版本日期)–修正後(如果有修改，請用不同顏色的字體標示修正處)
6. 受試者同意書(版本日期)–修正前
7. 受試者同意書(版本日期)–修正後(如果有修改，請用不同顏色的字體標示修正處)
8. 其餘相關申請資料，如參考文獻

台大醫院研究倫理委員會 王琦枚 謹上 2008/3/18

3/18 QOL assessment and Key in data

Mission:
1.Key in the data of BI and FAI that assessed in Yunlin Hospital.
2.QoL assessment for one p't,that talkative.
3.Reviewing the articles of the following:

懇請治療師代為協助事項
親愛的治療師您好：
為發展出一精確、有效與快速評量中風病人平衡與日常生活功能之工具，本研究欲結合測驗理論(項目反應理論(item response theory, IRT)之Rasch模式)以及嶄新施測技術之電腦化適性測驗(computerized adaptive test, CAT)，以提昇評估精確度與效率。懇請各位治療師協助代為處理事項如下：

1. 轉介符合以下標準之中風個案
(A) ADL item bank
收案標準：
(1) 診斷為中風患者(ICD-9：430~438)，不限定為首次中風。
(2) 可遵從施測者之指示(instruction)完成評估者。
(3) 病人若有其它重大疾病（如截肢、嚴重關節炎、惡性腫瘤等）可能影響其平衡表現者，不成為本研究之樣本。
(4) 願意參與本研究者。
(B) Balance item bank
收案標準：
(1) 診斷為中風患者(ICD-9：430~438)，不限定為首次中風。
(2) 可遵從施測者之指示(instruction)完成評估者。
(3) 病人若有其它重大疾病（如截肢、嚴重關節炎、惡性腫瘤等）可能影響其平衡表現者，不成為本研究之樣本。
(4) 願意參與本研究者。
(5) 單側偏癱或雙側偏癱但有明顯一側功能較差之中風個案。
(C) MAM
收案標準：
(1) 診斷為中風患者(ICD-9：430~438)，不限定為首次中風。
(2) 可遵從施測者之指示(instruction)完成評估者。
(3) 病人有基本的口語表達能力。
(4) 願意參與本研究者。
※ 住院病人(in-patients)或門診病人(OPD)符合上述收案標準者，由施測者對個案進行ADL item bank以及Balance item bank評估。目前進行一次的施測評估即可。

2. 簡單向個案說明研究目的後，給予個案同意書以確認意願。
3. 將願意參與研究之個案同意書交予研究人員。
4. 評估時尚需收集以下的個案基本資料：姓名、病歷號碼、病房/OPD、生日、性別、住院日期、開始復健的日期、患側、ICD-9編碼、中風次數、最近一次中風日期以及中風之腦部區域。
5. 為了讓收案的流程有效率，懇請您們協助準備一份符合標準者(住院或門診的中風病人)的名單。

個案表達願意參與研究後，研究人員會自行向個案約定測驗時間，並向治療師報備。全部測驗完成後，研究人員將會簡短地向治療師說明個案之測驗結果，或給予測驗結果影本。非常謝謝各位治療師的協助。若有任何疑問歡迎與我們聯絡。

施測者：台大職能治療學系 助理 吳宥慧 0961069064 / 羅慧珊 0956888223
主持人：台大職能治療學系 教授 謝慶麟 (02)33228177



研究程序說明
本研究之目的為發展具備精確、有效與快速評量中風病人平衡與日常生活功能之工具，以便協助專業人員擬定治療計劃與驗證療效，進而嘉惠病人並提升復健臨床工作之效率。本研究將使用五種量表來評估中風病人的平衡、上肢動作功能以及日常生活，例如ADL、BI、BIB、STREAM-UE以及自覺徒手功能量表。每次評估的時間為30-40分鐘。全部測驗一次完成，施測程序如下：

3/17 榮總PEP-3 asessment

Mission:
1.In the morning and afternoon, both have finished assessing 2 autism.
2.The children in the morning are nonverbal,few eye contact with tester,one of them has TD(tactile defensive),so he don't want to touch some materials of the assessment, like ......He also had difficulty imitating command of tester,low tone and poor posture,couldn't stand one foot independent,need tester helping.
3.The two children in the afternoon are more high function, like they can speak,well cognition ,just they have a little problem with the relationship.

3/15 到榮總評估的準備資料

懇請治療師代為協助事項
親愛的治療師您好：
為發展出一精確、有效與快速評量中風病人平衡與日常生活功能之工具，本研究欲結合測驗理論(項目反應理論(item response theory, IRT)之Rasch模式)以及嶄新施測技術之電腦化適性測驗(computerized adaptive test, CAT)，以提昇評估精確度與效率。懇請各位治療師協助代為處理事項如下：

1. 轉介符合以下標準之中風個案
(A) ADL item bank
收案標準：
(1) 診斷為中風患者(ICD-9：430~438)，不限定為首次中風。
(2) 可遵從施測者之指示(instruction)完成評估者。
(3) 病人若有其它重大疾病（如截肢、嚴重關節炎、惡性腫瘤等）可能影響其平衡表現者，不成為本研究之樣本。
(4) 願意參與本研究者。
(B) Balance item bank
收案標準：
(1) 診斷為中風患者(ICD-9：430~438)，不限定為首次中風。
(2) 可遵從施測者之指示(instruction)完成評估者。
(3) 病人若有其它重大疾病（如截肢、嚴重關節炎、惡性腫瘤等）可能影響其平衡表現者，不成為本研究之樣本。
(4) 願意參與本研究者。
(5) 單側偏癱或雙側偏癱但有明顯一側功能較差之中風個案。
(C) MAM
收案標準：
(1) 診斷為中風患者(ICD-9：430~438)，不限定為首次中風。
(2) 可遵從施測者之指示(instruction)完成評估者。
(3) 病人有基本的口語表達能力。
(4) 願意參與本研究者。
※ 住院病人(in-patients)或門診病人(OPD)符合上述收案標準者，由施測者對個案進行ADL item bank以及Balance item bank評估。目前進行一次的施測評估即可。

2. 簡單向個案說明研究目的後，給予個案同意書以確認意願。
3. 將願意參與研究之個案同意書交予研究人員。

個案表達願意參與研究後，研究人員會自行向個案約定測驗時間，並向治療師報備。全部測驗完成後，研究人員將會簡短地向治療師說明個案之測驗結果，或給予測驗結果影本。非常謝謝各位治療師的協助。若有任何疑問歡迎與我們聯絡。

施測者：台大職能治療學系 助理 吳宥慧 0961069064 / 羅慧珊 0956888223
主持人：台大職能治療學系 教授 謝慶麟 (02)33228177

研究程序說明
本研究之目的為發展具備精確、有效與快速評量中風病人平衡與日常生活功能之工具，以便協助專業人員擬定治療計劃與驗證療效，進而嘉惠病人並提升復健臨床工作之效率。本研究將使用六種量表來評估中風病人的平衡、上肢動作功能以及日常生活，例如ADL、BI、BIB、STREAM-UE以及自覺徒手功能量表。每次評估的時間為30-40分鐘。

3/14 stream-cat ,ADL ,BIB& QOL

Mission:
1.We have succed assessing one p't in the morning with the stream-CAT(paper sheet),because the PDA service inavailable.
2.But we have assessed 3P't in the afternoon with 2 QOL and 1ADL and BIB.

Questions:
1.If the patient was retired before get stroke, how do we interpret the items of 8 and 9(about the family role and work)?
2.We need to make sure the vision clearance of the patient before the test.

3/13 PEP-3 &writing BI &FAI.

Mission:
1.As the title,but the PEP-3 didnt have any assessment coz the children didnt come!
2.I have apply an half day off because i'm felt not so comfortable.

3/12 Writing the results of BI&FAI& helping Siny find p't

Mission:
1.Writing the results of BI & FAI.
2.週三下午 2：15，請至復健部 3 樓成人職能治療室（分機7313),幫忙安排病人給siny測試或觀察。初步只是測試臨床上中風病人對上肢的動作(手握緊)的數量.當天有搜尋到大約12位病患,以及3-4為住院病人(無法做握緊的動作).

3/11 中國IRB

Mission:
1.I got to fill in the items that not yet mention in the articles.
2.we have assessed 2QOL and 1ADL in the morning.

The questions of the IRB:
1.試驗類型為何種?
□其他：申請 臺灣大學醫學院與中國醫藥大學醫學院研究合作計畫

2.預計執行期間是否為 西元2008年5月1日起至2009年12月31日止?
OK

3.此IRB需要英文計畫書!
摘要，請由附檔（第3頁？）中找。

4.計畫書中需要先前的臨床試驗數據(參考文獻)
同之前的IRB計畫

5.主持人的資料/研究人員資料(我知道暫時先空下,以便提醒)
陳芬芬老師，若有未知者，請 highlight 標示之，請陳老師填寫。

6.預算經費表(仍然空白,不知道需要嗎?就我所知院內的就不需要,所以想再次確認這應該是中國藥的計畫吧!不需要的?)
先空白。

3/10 榮總醫院& NTUH peadtricPEP-3

Mission:
1,we have assessed 2 children (Autism)in 榮總醫院,both of them are typical autism.Their main characteristics are impairments in social interaction, impairments in communication, restricted interests and repetitive behavior.Repetitive behavior:
a.Stereotypy is apparently purposeless movement, such as hand flapping, head rolling, or body rocking.
b.Compulsive behavior is intended and appears to follow rules, such as arranging objects in a certain way.
c.Sameness is resistance to change; for example, insisting that the furniture not be moved or refusing to be interrupted.
d.Ritualistic behavior involves the performance of daily activities the same way each time, such as an unvarying menu or dressing ritual. This is closely associated with sameness and an independent validation has suggested combining the two factors.
e.Restricted behavior is limited in focus, interest, or activity, such as preoccupation with a single television programs.

2.we also arrange others appointment in next week.

3/7 PEP-3's translation

Mission:
1.I've finished translation the english-version PEP-3's to chinese version. Monday morning need to go to 榮總.
2.make a form of BI and FAI.
3.Key in the data(QOL,BIB,ADL)

3/6 WanFang H IRB & PEP-3

Mission:
1.1 ADL and BIB.
2.Correrting the respone booklet of PEP-3.
3.Recorrecting the IRB of the WanFang Hospital.


關於申請萬芳IRB已有回覆，有兩點需更改，第一個是"3.招募方式是否合理＝＞計畫書未看到有招募方式"
第二個在"受試者同意書"內"25.有新資訊會隨時通知受試者＝＞同意書未見有提到"，要麻煩您更改計畫書、計畫書摘要和受測者同意書的部分，另外還有IRB複審資料內的檔案審查意見回覆說明、和修改文件的前後對照等部分。我有附上檔案『台大OTIRB』，此檔案為初審送審的檔案，請用送審檔案更改，更改後改為version 2。
3月10日為複審的期限，請問是否可以在3月7日星期五前寄回給我，因為我需要時間列印裝訂成冊、貼標籤和請主任簽名，謝謝您。如果有任何問題可以和我聯絡02-29307930＃1612或IRB分機1466。

3/5 IRB, PEP-3 & QOL assessment.

Mission:
1.Today we have finished PEP-3 assessment in this morning.
2.And we have finished 4 questionaires with 2 patients in this afternoon.
3.Tommorrow need to review the IRB and finish before afternoon.

3/4 中國藥 IRB

Mission:
1.Writing the IRB of the 中國藥that need to finished before afternoon on wednesday.
2.Tommorrow i will recheck the contain of this IRB. Besides,i still have others items need to confirm with sir,the matter with the following:(還有以下一些資料需要補齊的:)

1.試驗類型為何種?
□廠商合作計畫
□通過 年度院內專題研究計畫
□申請 年度國科會計畫
□申請 年度學校專題研究計畫
□指導學生論文計畫
□其他
因為老師給我的檔案中只有說明是教研部計畫,且不清楚是否要寫程式中國藥的計畫嗎?所以我不清楚方向到底是何者?

2.預計執行期間是否為 西元2008年5月1日起至2009年12月31日止?

3.此IRB需要英文計畫書!

4.計畫書中需要先前的臨床試驗數據(參考文獻)

5.主持人的資料/研究人員資料(我知道暫時先空下,以便提醒)

6.預算經費表(仍然空白,不知道需要嗎?就我所知院內的就不需要,所以想再次確認這應該是中國藥的計畫吧!不需要的?)

3/3 Pep-3, BIB& ADL

Mission:
1.I have finished 1 BIB & ADL in the morning and have another 2 interviews in afternoon on Wednesday.
2.Next Monday we are planning go to 榮總小兒in the morning, they are arrange 2-3childrenon 9o'clock for us to test.
3.Today just finished 1 PEP-3 because another child absent and we also disscussing with teacher about the pictures from picture book. The pictures are not familar in Taiwan, like turkey etc.

3/1(SAT) work days

Mission:
1.I have finished Summarizing and individualizing the items of self-report QOL
2.Reminding the 慧珊about contacting 榮總's teacher 傅中珮 for having assessment PEP-3 at there on Monday.
3.Reading the article of the stroke patients' motor control problem and solving skills(hemiplegia).
4.Sir will give another IRB plan recently!

2/29 ADL &BIB assessment

Mission:
1.I have finished interviewing patients about the questionaires of QOL(1),BIB(2) and ADL(2).
2.Summarizing and individualizing the items of self-report QOL tomorrow and continue interviewing at least 10 patients.
3.Reminding the 慧珊about contact 榮總's teacher 傅中珮 for having assessment PEP-3 at there.
4.The second article need to pass up tomorrow morning to sir, don't be so lazy.

2/27 PEP-3 & ADL & IRB

Mission:
1.Next wednesday continue the test of the PEP-3 with same child (張).
2.Today i have finished 2ADL and 1 BIB,because one the patient are too weak to take part in BIB test.
3.review IRB:
申請臨床試驗IRB
(禮拜五不收件,因為他們要開會!)
台大:要申請證明,則臨床試驗計畫送件核對單多印一張交給林淑芳蓋章後即可領回(需蓋申請者章)

1、臨床試驗計畫送件核對單(置於首頁)(單獨一張)(左邊一整列不需要打勾,是由對方打的)
2、臨床試驗計劃申請書--最末頁上需蓋申請者章及單位主管章(醫院-部主任章，醫學院-科主任章)
3、臨床試驗計劃書(首頁右上角需加上計畫申請人及蓋章)
4、臨床試驗快速審查範圍評檢表(背面需蓋申請者章及單位主管章)
5、臨床試驗受試者說明及同意書(首頁需蓋主要主持人章)
-------第四項:需要註明:專有名詞(評估工具)的用途,評估的地點,時間長短以及次數.
6、問卷 (適當加入空白頁以方便列印排版)
7、參考文獻
8、主持人及協同研究人員之學經歷、著作及所受訓練之背景資料(首頁需蓋申請者章)
9、檔案附光碟、隨身碟或email至NTUHRE011@yahoo.com.tw
10、以上申請時訂為一份合計共需2份,送至東址B4(AB棟)研究倫理委員會辦公室(門口有門禁)，分機3155申請
最好全部單面列印(除臨床試驗計劃書可雙面列印)--現沒規定
11、倫委會網頁台大醫院/文件表格/醫學研究部之表格下載
http://intra.mc.ntu.edu.tw/default_Ehospital.asp
e-mail: shuhwai@ha.mc.ntu.edu.tw (檢察是否正確)
計劃時間更改變更
1.變更申請公文-簽一份
2.臨床試驗計畫申請書舊計劃時間第一,二張影本
3.新的臨床試驗計畫申請書,臨床試驗計畫書
高醫倫委會07-3121101-2396
國衛院02-26534401-23322

#因此需要檔案分開,在排版時較容易處理!

2/25 NTUH IRB(Fugl-Meyer & others)

Mission:
1.Writing the IRB of "Minimal Important Difference of a Motor Test and a Walking Speed Test for stroke patients"中風病人肢體動作量表及行走速度測驗之最小重要差異值. Besides, need to summarize and arangge the details of this article that can suitable with the IRB's rule.

2/24 PEP-3 & QOL assessment

Mission:
1.Another one QOL questionaire assessment has finished.
2.Today i have arranged 2 children take in with PEP-3. The first girl is a 慢熱型,another boy is overactive(always asking question and seeking help).Both of this two child are MR.

2/22 assessment

Mission:
1.Today morning i have interview with one p't with QOL.
2.review the definition of each domain of QOL and concepting the items.

2/21 assessment

Mission:
1.Correcting the questions' title of the QOL.
2.Reviewing the articles and the PEP-3.
3.If the FDT's author doesn't reply us in one week,then we have to send him a letter one more time.
4.Tomorrow we have appoinment with one p't for testing the QOL . .

2/20 assesment

Mission:
1.Today(morning) i have finished 2ADL& BIB.
2.Afternoon we are assessed one child with PEP-3.

2/19 assessment & others

Mission:
1.Today I have finished 2 ADL& BIB.
2.Correcting the IRB of the attention proposal[問卷要採無記名方式，所以問卷首頁不可有姓名、病歷號碼等可辨識受試者的資料，請刪除；可用流水編號等方式編碼]。,the letter of FDT and the questionaire of QOL.
3.Sending the mail to the FDT's author.

manuel@sedo.net
Subject: Request about FDT

Dear Sir/Madam,
Hi, I’m a research assistant in Taiwan. I’m very interested in using the FDT on our stroke patients. I would be grateful if you could give me a suggestions about the following questions.1. Does the FDT have the Mandarin version, if so how could I get it? Does the Mandarin version have any copyright? 2. On the contrary, if doesn’t have the Mandarin version of the FDT, does it need an authorized translation if we would like to translate the FDT to Mandarin? Looking forward to receiving your reply soon, and thank you so much for your help!!


Yours sincerely,
Yew-Hooi Goh

2/18 assessment

Mission:
1.Today i have finished 1 BIB and ADL.
2.I'm correcting the article and summarizing the new questionaire about stroke patients' quality of life.

2/15 NTUH's clinical assessment

Mission:
1. 盡快熟悉 PEP3 之實際施測，請找小朋友或與宥慧相互練習。
2. 協助修改/確認 PEP3 之施測手冊。
3. 訪談中風病人對中風帶給他們的影響或重要性-SS-QOL,SIS,BOS & 其它.
4. ADL/IADL 。
5.Writing the letter to the FDT test's author about how to use the FDT test on chinese patients.

2/14 NTUH's clinical assessment

Mission:
1.Today I have finished 1 IADL & BIB.
2.Reading PEP3 and review the translation article.
3.Planning and thinking the main mission in the Future.

2/13 NTUH's clinical assessment

Mission:
1.Today i have finished ADL and BIB.
2.i have already make an appointment with 姜老師on next wednesday morning.

1/23 NTUH's clinical assessment

Mission:
1.Today ,we are the first time to testing PEP-3 on an autism child(about 2yrs/o),and we will continue the test on next wednesday.
2.Conclusion:
-we still need more practice to be more skilled and efficiency.
-the attention of the child just can maintain at least 30minutes,or not he will not co-operation in the testing.

1/22 NTUH's clinical assessment

Mission:
1.Today I've finished 2 BIB & ADL's questionaire.
2.Tomorrow have a appointment with 姜老師 for testing the PEP-3
3.Beside,we have finished the chinese translation and make some card of the respone booklet.

1/21 PEP-3 & IRB project

Mission:
1.Discussion about how to change of the PEP-3 form(Drawing book)
2.i'm writing the form of the WanFang's IRB.

1/16 Work time

Mission:

1. Today i have finished 2 ADL and BIB.
2. Practice PEP-3 with Hui Shan, and disscussion with teacher.
3. 台大IRB
案件編號 協同主持人
200712113R 職能治療學系 薛漪平助理教授
計畫名稱 四種注意力測驗應用於中風患者所評量之注意力類別與實用功能
表格發出日期： 96年12月29日
審查意見
快速審查結果:
■符合快速審查條件，惟應修正：
審查意見：
請將受試者同意書四、倒數第二行2個「個案」修改為「您」，並請修飾此行文句。

1/17 Work time

Mission:
1.Need to finish the project on MOnday!
2.PEP-3的圖畫本和塗鴉書計畫在禮拜一修改完成。

在摘要的部分IRB說只需要兩頁，格式有更新（附上新的格式）。
在受測者同意書內需要填24小時聯絡方式必須是手機，麻煩您再給我資料（研究人員亦可）。
另外，IRB規定協同主持人也需要GCP訓練證明9學分，下面是取得證明的方式，每個課程式一小時，麻煩您了，請問，需要老師簽名的部分應該怎麼取得？

請參閱下述說明

請您撥空登入 CITI網址: https://www.citiprogram.org/ ,以進行相關人體試驗認證訓練課程
一開始先選擇 New Users Register Here
Participating Institutions:
Joint Institutional Review Board-Taiwan
其他3項都留空
之後輸入username , password, 最後加入的時候選擇 Investigator 即可
登入CITI進行相關考試(約20分鐘),當您完成後請印出完成認證證明,即可
目前衛生署的要求為3年9小時, CITI的課程被視為每個課程1小時
如有疑問請來電IRB或是參閱附件試題相關資料
96315@wanfang.gov.tw
02-29307930-1466
萬芳醫院人體試驗委員會
Wanfang Hospital IRB

1/14 萬芳醫院[個案報告]

Mission:

1.萬芳醫院[個案報告]的內容,只要包含收集的問卷或分析的資料檔案或輸入電腦的資料參數的格式.
2.將PEP-3的題目複習完畢,明天將問題跟老師討論,禮拜三和慧珊互相施測.

1/9 NTUH clinical assessment

Mission:
1. I have finished 4ADL, 3BIB and 1FDT.
2. Having a appointment on next Monday with Mr.Zhang!
3. 姜&黃老師are busy recently, so i decided that i will practice with 慧珊in the future(may be next wednesday).

1/7 NTUH clinical assessment

Mission:
1.Today finished 2ADL ,BIB and FDT.
2.i'm still not yet finished looking through all the PEP-3 testing materials.I have required 姜老師 about the administration of PEP-3,they not yet practiced,and i will make apointment with them on next administration of PEP-3.
And I have some questions of the PEP-3,need some time to figure out and reconstruct the step of administration.

1/4 NTUH clinical assessment

Mission:
1.Today finished 1FDT,4BIB and 3ADL.
2. Please have a look at two files attached which are a brief introduction and manual of the PEP-3.
3.4.Please have a look and go to the clinic to ask 姜或黃暐恬 about the testing materials.
Ans: i will use the free time testing the material on Monday
4.next week have appointment with 2 p't(Mr.chen-before 2.30pm & Mrs.lin after treatment).

1/3 NTUH clinical assessment

Mission:
1.Today finished 2FDT,3BIB and 3ADL.
2.If sir didn't send mail to me tomorrow,need to remind him again.
3. Please have a look at two files attached which are a brief introduction and manual of the PEP-3.
4.Please have a look and go to the clinic to ask 姜或黃暐恬 about the testing materials.

1/2 Mission

Mission:

1.把ADL跟BIB分成2個excel檔,你可以把不同醫院的ADL(or balance)放在同一個檔不同分頁裡,因為這樣Chia-Lin匯整會比較容易.
2.NTUH clinical assessment:
Today completed 2BIB, 1ADL and 2FDT.
Tommorrow afternoon have appointment with 2 p't(BIB,ADL or FDT)

Review:
I have questions regarding the Chinese version of FDT:
1.I’m confused about the stopping time that showed in the answer sheet at two different time? What is the function?
2.How do I use the time and the numbers of correct items to interpret the patient’s function?
3.Can patients use their finger to point at each box to help them focus while counting numbers in each box?
4.Is the patient allowed to correct their answer during test?