ID

33708

Beskrivning

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Nyckelord

Versioner (3)
  1. 2018-12-12 2018-12-12 -
  2. 2018-12-20 2018-12-20 -
  3. 2018-12-20 2018-12-20 -
Rättsinnehavare

GSK group of companies

Uppladdad den

20 december 2018

DOI

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Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

Engelsk

Visit 20: Prior and Concomitant Medications + Gen-consent

1 Formulär  
Administrative data
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Administrative data

Site
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Site

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text

Subject
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Subject

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text

Visit Name
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Visit Name

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text

Status
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Status

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text

Doc №
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Doc №

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integer

Is Page Blank?
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blank page?

Datatyp

boolean

Prior and Concomitant Medications/Non-Drug Therapies
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Prior and Concomitant Medications/Non-Drug Therapies

Concomitant Medication
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Concomitant Medication

Datatyp

boolean

Non-Drug Therapy
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including procedures and surgeries

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boolean

Drug Name
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Trade name preferred

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text

Unit Dose
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Unit Dose

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text

Unit
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Unit

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text

Frequency
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Frequency

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text

Route
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Route

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text

Indication
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If AE/SAE enter Event Term

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text

AE/SAE Event Number
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AE/SAE Event Number

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integer

Start date
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Start date

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date

Stop date
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Stop date

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date

Ongoing?
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Ongoing?

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boolean

Taken prior to study?
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Taken prior to study?

Datatyp

boolean

PGx-Pharmacogenetic Research Consent
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PGx-Pharmacogenetic Research Consent

Has the informed consent been obtained for PGx-Pharmacogenetic Research?
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Has the informed consent been obtained for PGx-Pharmacogenetic Research?

Datatyp

boolean

Date informed consent obtained
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Date informed consent obtained

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date

If no consent obtained, check the reason
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If no consent obtained, check the reason

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text

If other, specify
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If other, specify

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text

Blood Sample
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Blood Sample

Has a blood sample been collected for PGx research?
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Has a blood sample been collected for PGx research?

Datatyp

boolean

Record the date sample taken
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Record the date sample taken

Datatyp

date

If no, check the reason
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If no, check the reason

Datatyp

text

If Other, specify
Beskrivning

If Other, specify

Datatyp

text

PGx-Pharmacogenetic Research Consent Withdrawal
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PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beskrivning

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Datatyp

boolean

Has a request been made for sample destruction?
Beskrivning

Has a request been made for sample destruction?

Datatyp

boolean

If Yes, enter the reason
Beskrivning

If Yes, enter the reason

Datatyp

text

If Other, specify
Beskrivning

If Other, specify

Datatyp

text

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Visit 20: Prior and Concomitant Medications + Gen-consent

1 Formulär
Name
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Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
Adverse Events (1)
Status
Item
Status
text
Doc №
Item
Doc №
integer
blank page?
Item
Is Page Blank?
boolean
Item Group
Prior and Concomitant Medications/Non-Drug Therapies
Concomitant Medication
Item
Concomitant Medication
boolean
Non-Drug Therapy
Item
Non-Drug Therapy
boolean
Drug Name
Item
Drug Name
text
Unit Dose
Item
Unit Dose
text
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Indication
Item
Indication
text
AE/SAE Event Number
Item
AE/SAE Event Number
integer
Start date
Item
Start date
date
Stop date
Item
Stop date
date
Ongoing?
Item
Ongoing?
boolean
Taken prior to study?
Item
Taken prior to study?
boolean
Has the informed consent been obtained for PGx-Pharmacogenetic Research?
Item
Has the informed consent been obtained for PGx-Pharmacogenetic Research?
boolean
Date informed consent obtained
Item
Date informed consent obtained
date
Item
If no consent obtained, check the reason
text
If no consent obtained, check the reason
Code List
If no consent obtained, check the reason
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other (3)
If other, specify
Item
If other, specify
text
Item Group
Blood Sample
Has a blood sample been collected for PGx research?
Item
Has a blood sample been collected for PGx research?
boolean
Record the date sample taken
Item
Record the date sample taken
date
Item
If no, check the reason
text
If no, check the reason
Code List
If no, check the reason
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Item Group
PGx-Pharmacogenetic Research Consent Withdrawal
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
Item
If Yes, enter the reason
text
If Yes, enter the reason
Code List
If Yes, enter the reason
CL Item
Subject requested (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
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