ID

32433

Descrizione

This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log as well as the investigator's signature. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Keywords

versioni (4)
  1. 21/10/18 21/10/18 -
  2. 28/10/18 28/10/18 -
  3. 30/10/18 30/10/18 -
  4. 31/10/18 31/10/18 -
Titolare del copyright

GlaxoSmithKline

Caricato su

31 ottobre 2018

DOI

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Licenza

Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

Inglese

Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

1 moduli  
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Date
Descrizione

Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0011008
Study Conclusion
Descrizione

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Descrizione

Date of subject completion or withdrawal

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0422727
UMLS CUI [2]
C1549507
Time of withdrawal
Descrizione

Time of withdrawal

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Descrizione

INVESTIGATOR INSTRUCTIONS • Refer to protocol section(s) 11to evaluate subject completion or withdrawal from the study. • If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. • If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. • If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports. MONITOR DATA VALIDATION CHECKS • If the investigational product was discontinued at the same time as the subject was withdrawn from the study, ensure the reasons for the two discontinuations are consistent.

Tipo di dati

text

Alias
UMLS CUI [1]
C0422727
If Yes, check the primary reason for withdrawal:
Descrizione

• If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event: • ’Withdrawal’ on the AE/SAE page is recorded as ’Yes’. • ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE/SAE’ on the AE/SAE page is recorded as ’Investigational Product Withdrawn’. • ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Other, specify
Descrizione

Other reason for withdrawal, specification

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Pregnancy Information
Descrizione

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Descrizione

If Yes, complete Pregnancy Notification form.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Investigator Comment Log
Descrizione

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Descrizione

CRF page number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Descrizione

Comment

Tipo di dati

text

Alias
UMLS CUI [1]
C0947611
Investigator's Signature
Descrizione

Investigator's Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's signature
Descrizione

Investigator's Signature

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Descrizione

Investigator's name

Tipo di dati

text

Alias
UMLS CUI [1]
C2826892
Date
Descrizione

Investigator's signature: Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Time of withdrawal
Item
Time of withdrawal
time
C0422727 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Was the subject withdrawn from the study?
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, check the primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
The primary reason for withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event  (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Other (Z)
Other reason for withdrawal, specification
Item
Other, specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during the study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner)  (X)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF page number if applicable
text
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Investigator's signature: Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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