ID

27361

Description

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

Keywords

Versions (3)
  1. 11/9/17 11/9/17 -
  2. 11/9/17 11/9/17 -
  3. 11/26/17 11/26/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 9, 2017

DOI

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License

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

English

Screen visit GSK study Prostatic neoplasms NCT00883909

1 forms  
Administrative data
Description

Administrative data

Session number
Description

Session number

Data type

integer

Subject number
Description

Subject number

Data type

text

Previous Subject number
Description

Previous Subject number

Date of assessment
Description

Date of assessment

Data type

date

Previous Subject Number from the REDUCE (ARI40006) Study
Description

Previous Subject Number

Data type

text

Inclusion / Exclusion Criteria Worksheet
Description

Inclusion / Exclusion Criteria Worksheet

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

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

Data type

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?
Description

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

Data type

text

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

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

Data type

text

Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

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

See INCLUSION / EXCLUSION CRITERIA WORKSHEET.

Data type

text

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

informed consent violation

Data type

boolean

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

eligibility criteria violation

Data type

boolean

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

participation in Follow-Up Study telephone calls violation

Data type

boolean

Eligibility Criteria
Description

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.
Description

eligibility part A

Data type

boolean

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

Part A Eligibility Criteria

Data type

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.
Description

eligibility part B

Data type

boolean

Investigator’s Statement
Description

Investigator’s Statement

Date
Description

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.

Data type

date

Investigator’s Signature
Description

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."

Data type

text

Investigator’s Name - Print
Description

Investigator’s Name

Data type

text

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Similar models

Screen visit GSK study Prostatic neoplasms NCT00883909

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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