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Informações:
Falhas:
ID
32648
Descrição
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension
Palavras-chave
Versões (2)
- 09/11/2018 09/11/2018 -
- 11/01/2019 11/01/2019 -
Titular dos direitos
GSK group of companies
Transferido a
9 de novembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904
Pregnancy Notification Form
- StudyEvent: ODM
Similar models
Pregnancy Notification Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Identifier
Item
Subject Identifier
integer
Centre Number
Item
Centre Number
integer
Randomisation Number
Item
Randomisation Number
integer
Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GSK by mail or fax within two weeks of learning of the pregnancy. Ensure the relevan information in the electronic Case Report Form is updated
Item
Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GSK by mail or fax within two weeks of learning of the pregnancy. Ensure the relevan information in the electronic Case Report Form is updated
text
Mother's date of birth
Item
Mother's date of birth
date
Date of last menstrual period
Item
Date of last menstrual period
date
Estimated date of delivery
Item
Estimated date of delivery
date
Was the mother using a method of contraception?
Item
Was the mother using a method of contraception?
boolean
If YES, specify
Item
text
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures
text
Number of previous pregnancies pre-term
Item
Number of previous pregnancies pre-term
integer
Number of previous pregnancies full-term
Item
Number of previous pregnancies full-term
integer
Item Group
If applicable, record the number in the appropriate categories below:
Normal births
Item
Normal births
integer
Stillbirths
Item
Stillbirths
integer
Children born with defects
Item
Children born with defects
integer
Spontaneous abortion
Item
Spontaneous abortion
integer
Elective abortion
Item
Elective abortion
integer
Other
Item
Other
integer
Record details of children born with defects
Item
Record details of children born with defects
text
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
boolean
If YES, specify
Item
If YES, specify
text
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects /genetic /chromosomal disorders and medication use
Item
Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects /genetic /chromosomal disorders and medication use
text
List all medications (including study medications) the subject received during the study period. Enter the investigational product details on the first line. If there are extensive concomitant medications, attach a copy of the concomitant Medications CRF screen.
Item
List all medications (including study medications) the subject received during the study period. Enter the investigational product details on the first line. If there are extensive concomitant medications, attach a copy of the concomitant Medications CRF screen.
text
Drug Name
Item
Drug Name
text
Route of Administration or Formulation
Item
Route of Administration or Formulation
text
Total Daily Dose
Item
Total Daily Dose
float
Units
Item
Units
text
Started Pre-Study?
Item
Started Pre-Study?
boolean
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication?
Item
Ongoing Medication?
boolean
Reason for Medication
Item
Reason for Medication
text
Was the subject withdrawn from the study as a result of this pregnancy?
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
Name
Item
Name
text
Title
Item
Title
text
Speciality
Item
Speciality
text
Address
Item
Address
text
City or State/Province
Item
City or State/Province
text
Country
Item
Country
text
Post or ZIP Code
Item
Post or ZIP Code
text
Telephone Number
Item
Telephone Number
integer
Fax Number
Item
Fax Number
integer
Investigator's signature
Item
Investigator's signature
text
Investigator's name (Print)
Item
Investigator's name (Print)
text
Date
Item
Date
date