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Person

19 forms  
Personal identification number (ID)
Description

Personal identification number (ID)

Which personal identification number (ID) is assigned to the patient?
Description

PERSON_ID

Data type

string

Declaration of consent (patient)
Description

Declaration of consent (patient)

Is there a declaration of consent from the patient/participant for the study?
Description

PERSON_CONSENT

Data type

text

Exact date of inclusion or consent of the patient
Description

PERSON_CONSENT_SIGNDATE

Data type

date

Exact date of the version of the signed consent form
Description

PERSON_CONSENT_VERSION

Data type

date

Was the consent form withdrawed? What was requested in the withdrawal?
Description

PERSON_CONSENT_WITHDRAWAL_Q

Data type

text

When was the withdrawal submitted?
Description

PERSON_CONSENT_WITHDRAWAL_DATE

Data type

date

Which releases/permissions were not given, but would have been possible according to the declaration of consent?
Description

PERSON_CONSENT_WITHDRAWAL

Data type

text

Which other releases/permissions were not given?
Description

PERSON_CONSENT_WITHDRAWAL_OTHER

Data type

text

Study inclusion and endpoint
Description

Study inclusion and endpoint

Is the patient included as a patient or as a healthy volunteer?
Description

PERSON_STUDY_INCLUSION_PARTICIPANT_TYPE

Data type

text

Reason for study inclusion
Description

PERSON_STUDY_INCLUSION_REASON

Data type

text

Study endpoint for participants
Description

PERSON_STUDY_ENDPOINT

Data type

text

Is the date of death known?
Description

PERSON_DEATH_DATE_Q

Data type

text

Exact date of death
Description

PERSON_DEATH_DATE

Data type

date

Demographics
Description

Demographics

Age (at the time of informed consent)
Description

PERSON_DEMOG_AGE

Data type

integer

Unit of age (at the time of informed consent)
Description

PERSON_DEMOG_AGE_UNIT

Data type

text

Sex (biological at birth)
Description

PERSON_DEMOG_SEX

Data type

text

What other biological sex was determined after birth?
Description

PERSON_DEMOG_SEX_OTHER

Data type

text

Administrative gender as stated in passport/insurance card
Description

PERSON_DEMOG_GENDER

Data type

text

Ethnicity/origin
Description

PERSON_DEMOG_ETHNICITY

Data type

text

Participation in other clinical trials
Description

Participation in other clinical trials

Has the patient participated in one or more interventional clinical trials that were not organized via the DZIF?
Description

PERSON_OTHER_CLINICAL_STUDIES_Q

Data type

text

Is the EudraCT or NCT number available?
Description

PERSON_OTHER_CLINICAL_STUDIES_NO_Q

Data type

text

Please state EudraCT or NCT number
Description

PERSON_OTHER_CLINICAL_STUDIES_NO

Data type

string

Which number was given in the previous question?
Description

PERSON_OTHER_CLINICAL_STUDIES_NO_UNIT

Data type

text

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Similar models

Person

19 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Personal identification number (ID)
PERSON_ID
Item
Which personal identification number (ID) is assigned to the patient?
string
Item Group
Declaration of consent (patient)
Item
Is there a declaration of consent from the patient/participant for the study?
text
CL.1
Code List
Is there a declaration of consent from the patient/participant for the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Restricted (P)
CL Item
No information available (X)
PERSON_CONSENT_SIGNDATE
Item
Exact date of inclusion or consent of the patient
date
PERSON_CONSENT_VERSION
Item
Exact date of the version of the signed consent form
date
Item
Was the consent form withdrawed? What was requested in the withdrawal?
text
CL.3
Code List
Was the consent form withdrawed? What was requested in the withdrawal?
CL Item
Anonymization (ANO)
CL Item
Deletion (DEL)
CL Item
No information available (X)
PERSON_CONSENT_WITHDRAWAL_DATE
Item
When was the withdrawal submitted?
date
Item
Which releases/permissions were not given, but would have been possible according to the declaration of consent?
text
CL.97
Code List
Which releases/permissions were not given, but would have been possible according to the declaration of consent?
CL Item
Biospecimen collection permission withdrawn (BIO)
CL Item
No permission contacting co-treaters (CC)
CL Item
No permission to use health insurance data (HI)
CL Item
No permission to use routine clinical data (hospital) (HCRD)
CL Item
No permission to use routine clinical data (medical practices) (PCRD)
CL Item
No permission to recontact the patient (RP)
CL Item
No permission to transfer data/samples within the EU (EU)
CL Item
No permission to transfer data/samples outside the EU (NEU)
CL Item
No permission to use data for commercial use (CU)
CL Item
Further release(s) withdrawn (OTHER)
PERSON_CONSENT_WITHDRAWAL_OTHER
Item
Which other releases/permissions were not given?
text
Item Group
Study inclusion and endpoint
Item
Is the patient included as a patient or as a healthy volunteer?
text
CL.4
Code List
Is the patient included as a patient or as a healthy volunteer?
CL Item
Patient (P)
CL Item
Control (C)
PERSON_STUDY_INCLUSION_REASON
Item
Reason for study inclusion
text
Item
Study endpoint for participants
text
CL.5
Code List
Study endpoint for participants
CL Item
Patient is still active in the study (AK)
CL Item
Patient has regularly completed study, alive at home (AL)
CL Item
Patient was admitted to hospital (HO)
CL Item
Patient was discharged to rehab (RE)
CL Item
Patient was transferred to long-term care facility (LTCF)
CL Item
Patient was referred to another facility (non-palliative) (TR)
CL Item
Patient has been discharged or referred for palliative care (PA)
CL Item
Patient has died (DE)
CL Item
Loss-to-follow-up: Patient ended study prematurely (X1)
CL Item
Loss-to-follow-up: Patient can no longer be contacted/traced (X2)
CL Item
Loss-to-follow-up n.a. (XX)
CL Item
Study endpoint unknown (X)
Item
Is the date of death known?
text
CL.2
Code List
Is the date of death known?
CL Item
Yes (Y)
CL Item
No (N)
PERSON_DEATH_DATE
Item
Exact date of death
date
Item Group
Demographics
PERSON_DEMOG_AGE
Item
Age (at the time of informed consent)
integer
Item
Unit of age (at the time of informed consent)
text
CL.6
Code List
Unit of age (at the time of informed consent)
CL Item
Years (YEAR)
CL Item
Months (MONTH)
Item
Sex (biological at birth)
text
CL.7
Code List
Sex (biological at birth)
CL Item
Male (M)
CL Item
Female (F)
CL Item
Other (OTHER)
PERSON_DEMOG_SEX_OTHER
Item
What other biological sex was determined after birth?
text
Item
Administrative gender as stated in passport/insurance card
text
CL.8
Code List
Administrative gender as stated in passport/insurance card
CL Item
Male (M)
CL Item
Female (F)
CL Item
Diverse/non-binary (D)
CL Item
Undetermined/unspecified (X)
Item
Ethnicity/origin
text
CL.9
Code List
Ethnicity/origin
CL Item
Caucasian (CAUCASIAN)
CL Item
African (AFRICAN)
CL Item
Asian (ASIAN)
CL Item
Arab (ARABIC)
CL Item
Latino (LATAMERICAN)
CL Item
Mixed ethnicity (MIXED)
CL Item
Other (OTHER)
CL Item
No information available (X)
Item Group
Participation in other clinical trials
Item
Has the patient participated in one or more interventional clinical trials that were not organized via the DZIF?
text
CL.10
Code List
Has the patient participated in one or more interventional clinical trials that were not organized via the DZIF?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
No information available (X)
Item
Is the EudraCT or NCT number available?
text
CL.100
Code List
Is the EudraCT or NCT number available?
CL Item
Yes (Y)
CL Item
No (N)
PERSON_OTHER_CLINICAL_STUDIES_NO
Item
Please state EudraCT or NCT number
string
Item
Which number was given in the previous question?
text
CL.11
Code List
Which number was given in the previous question?
CL Item
EudraCT number (EUCT)
CL Item
NCT number (NCT)
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