ID

33708

Beschrijving

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

Trefwoorden

Versies (3)
  1. 12-12-18 12-12-18 -
  2. 20-12-18 20-12-18 -
  3. 20-12-18 20-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

20 december 2018

DOI

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Licentie

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

Engels

Visit 20: Prior and Concomitant Medications + Gen-consent

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

Status
Beschrijving

Status

Datatype

text

Doc №
Beschrijving

Doc №

Datatype

integer

Is Page Blank?
Beschrijving

blank page?

Datatype

boolean

Prior and Concomitant Medications/Non-Drug Therapies
Beschrijving

Prior and Concomitant Medications/Non-Drug Therapies

Concomitant Medication
Beschrijving

Concomitant Medication

Datatype

boolean

Non-Drug Therapy
Beschrijving

including procedures and surgeries

Datatype

boolean

Drug Name
Beschrijving

Trade name preferred

Datatype

text

Unit Dose
Beschrijving

Unit Dose

Datatype

text

Unit
Beschrijving

Unit

Datatype

text

Frequency
Beschrijving

Frequency

Datatype

text

Route
Beschrijving

Route

Datatype

text

Indication
Beschrijving

If AE/SAE enter Event Term

Datatype

text

AE/SAE Event Number
Beschrijving

AE/SAE Event Number

Datatype

integer

Start date
Beschrijving

Start date

Datatype

date

Stop date
Beschrijving

Stop date

Datatype

date

Ongoing?
Beschrijving

Ongoing?

Datatype

boolean

Taken prior to study?
Beschrijving

Taken prior to study?

Datatype

boolean

PGx-Pharmacogenetic Research Consent
Beschrijving

PGx-Pharmacogenetic Research Consent

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

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

Datatype

boolean

Date informed consent obtained
Beschrijving

Date informed consent obtained

Datatype

date

If no consent obtained, check the reason
Beschrijving

If no consent obtained, check the reason

Datatype

text

If other, specify
Beschrijving

If other, specify

Datatype

text

Blood Sample
Beschrijving

Blood Sample

Has a blood sample been collected for PGx research?
Beschrijving

Has a blood sample been collected for PGx research?

Datatype

boolean

Record the date sample taken
Beschrijving

Record the date sample taken

Datatype

date

If no, check the reason
Beschrijving

If no, check the reason

Datatype

text

If Other, specify
Beschrijving

If Other, specify

Datatype

text

PGx-Pharmacogenetic Research Consent Withdrawal
Beschrijving

PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschrijving

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Datatype

boolean

Has a request been made for sample destruction?
Beschrijving

Has a request been made for sample destruction?

Datatype

boolean

If Yes, enter the reason
Beschrijving

If Yes, enter the reason

Datatype

text

If Other, specify
Beschrijving

If Other, specify

Datatype

text

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Visit 20: Prior and Concomitant Medications + Gen-consent

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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