ID

27360

Beschreibung

Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate CRF Seiten: 934-977

Stichworte

Versionen (3)
  1. 09.11.17 09.11.17 -
  2. 09.11.17 09.11.17 -
  3. 26.11.17 26.11.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. November 2017

DOI

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Creative Commons BY-NC 3.0
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Screen visit GSK study Prostate neoplasms NCT00883909

Englisch

Screen visit GSK study Prostate neoplasms NCT00883909

1 Formulare  
Administrative data
Beschreibung

Administrative data

Session number
Beschreibung

Session number

Datentyp

integer

Subject number
Beschreibung

Subject number

Datentyp

text

Previous Subject number
Beschreibung

Previous Subject number

Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Previous Subject Number from the REDUCE (ARI40006) Study
Beschreibung

Previous Subject Number

Datentyp

text

Inclusion / Exclusion Criteria Worksheet
Beschreibung

Inclusion / Exclusion Criteria Worksheet

Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
Beschreibung

If the INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Datentyp

text

Inclusion criteria: 2. Did the subject participate in the REDUCE Study and meet the eligibility criteria for Part A, the 2 Year Observational Follow-Up Study and/or Part B, the Prostate Biopsy Tissue Study?
Beschreibung

If the INCLUSION CRITERIA question is answered NO, this subject must NOT enter this study.

Datentyp

text

Exclusion criteria (Part A only): 1. Is the subject unable/unwilling to participate in the Follow-Up Study telephone calls?
Beschreibung

If any EXCLUSION CRITERIA question is answered YES, this subject must NOT enter this study.

Datentyp

text

Inclusion/Exclusion Criteria
Beschreibung

Inclusion/Exclusion Criteria

Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
Beschreibung

See INCLUSION / EXCLUSION CRITERIA WORKSHEET.

Datentyp

text

Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 1.
Beschreibung

informed consent violation

Datentyp

boolean

Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 2.
Beschreibung

eligibility criteria violation

Datentyp

boolean

Check all boxes that represent a violation of the inclusion / exclusion criteria: Exclusion criteria 1.
Beschreibung

participation in Follow-Up Study telephone calls violation

Datentyp

boolean

Eligibility Criteria
Beschreibung

Eligibility Criteria

1. Part A: Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria for Part A, 2 Year Observational Follow-Up Study.
Beschreibung

eligibility part A

Datentyp

boolean

If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
Beschreibung

Part A Eligibility Criteria

Datentyp

text

2. Part B: Any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the REDUCE Study, regardless of when their REDUCE study participation ended.
Beschreibung

eligibility part B

Datentyp

boolean

Investigator’s Statement
Beschreibung

Investigator’s Statement

Date
Beschreibung

Sign and date this page after all relevant Screening CRF pages, including outstanding test results, are completed. Check that the date of signature is on or after the completion of the Screening Visit.

Datentyp

date

Investigator’s Signature
Beschreibung

Sign and date this page after all relevant Screening CRF pages, including outstanding test results, are completed. "I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date."

Datentyp

text

Investigator’s Name - Print
Beschreibung

Investigator’s Name

Datentyp

text

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Ähnliche Modelle

Screen visit GSK study Prostate neoplasms NCT00883909

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Session number
Item
Session number
integer
Subject number
Item
Subject number
text
Item Group
Previous Subject number
Date of assessment
Item
Date of assessment
date
Previous Subject Number
Item
Previous Subject Number from the REDUCE (ARI40006) Study
text
Item Group
Inclusion / Exclusion Criteria Worksheet
Item
Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
text
informed consent
Code List
Inclusion criteria: 1. Has the subject signed and dated a written informed consent?
CL Item
Yes (Y)
CL Item
No (N)
Item
Inclusion criteria: 2. Did the subject participate in the REDUCE Study and meet the eligibility criteria for Part A, the 2 Year Observational Follow-Up Study and/or Part B, the Prostate Biopsy Tissue Study?
text
informed consent
Code List
Inclusion criteria: 2. Did the subject participate in the REDUCE Study and meet the eligibility criteria for Part A, the 2 Year Observational Follow-Up Study and/or Part B, the Prostate Biopsy Tissue Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Exclusion criteria (Part A only): 1. Is the subject unable/unwilling to participate in the Follow-Up Study telephone calls?
text
informed consent
Code List
Exclusion criteria (Part A only): 1. Is the subject unable/unwilling to participate in the Follow-Up Study telephone calls?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion/Exclusion Criteria
Item
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
text
informed consent
Code List
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
CL Item
Yes (Y)
CL Item
No (N)
informed consent violation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 1.
boolean
eligibility criteria violation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Inclusion criteria 2.
boolean
participation in Follow-Up Study telephone calls violation
Item
Check all boxes that represent a violation of the inclusion / exclusion criteria: Exclusion criteria 1.
boolean
Item Group
Eligibility Criteria
eligibility part A
Item
1. Part A: Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria for Part A, 2 Year Observational Follow-Up Study.
boolean
Item
If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
text
Part A Eligibility Criteria
Code List
If Part A is checked, indicate which one of the following Part A Eligibility Criteria the subject meets:
CL Item
Completed 4 years on Investigational Product through the REDUCE 4-Year Study Visit (Visit 10). (a)
CL Item
Was diagnosed with prostate cancer during the REDUCE study, discontinued Investigational Product but participated in REDUCE prostate cancer follow-up visits through the 4-Year Study Visit (Visit 10P). (b)
CL Item
Withdrew from REDUCE study visit participation and Investigational Product (for any reasons) but participated in REDUCE follow-up phone calls every 6 months through the 4 Year Phone Call. (c)
eligibility part B
Item
2. Part B: Any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the REDUCE Study, regardless of when their REDUCE study participation ended.
boolean
Item Group
Investigator’s Statement
Date
Item
Date
date
Investigator’s Signature
Item
Investigator’s Signature
text
Investigator’s Name
Item
Investigator’s Name - Print
text
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