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D -Patient Characteristics
D.1 -Patient (name or initials)
D.1.1.1 -Patient Medical Record Number(s) and the Source(s) of the Record Number (GP Medical Record Number)
D.1.1.2 -Patient Medical Record Number(s) and the Source(s) of the Record Number (Specialist Record Number)
D.1.1.3 -Patient Medical Record Number(s) and the Source(s) of the Record Number (Hospital Record Number)
D.1.1.4 -Patient Medical Record Number(s) and the Source(s) of the Record Number (Investigation Number)
D.3 -Body Weight (kg)
D.4 -Height (cm)
D.5 -Sex
D.6 -Last Menstrual Period Date
D.7.2 -Text for Relevant Medical History and Concurrent Conditions (not including reaction /event)
D.7.3 -Concomitant Therapies
D.9.1 -Date of Death
D.9.3 -Was Autopsy Done?
D -Patient Characteristics
D.2.1 -Date of Birth
D.2.2a -Age at Time of Onset of Reaction /Event (number)
D.2.2b -Age at Time of Onset of Reaction /Event (unit)
D.2.2.1a -Gestation Period When Reaction /Event Was Observed in the Foetus (number)
D.2.2.1b -Gestation Period When Reaction /Event Was Observed in the Foetus (unit)
D.2.3 -Patient Age Group (as per reporter)
D.2 -Age Information
D.8.r.1 -Name of Drug as Reported
D.8.r.2a -MPID Version Date /Number
D.8.r.2b -Medicinal Product Identifier (MPID)
D.8.r.3a -PhPID Version Date /Number
D.8.r.3b -Pharmaceutical Product Identifier (PhPID)
D.8.r.4 -Start Date
D.8.r.5 -End Date
D.8.r.6a -MedDRA Version for Indication
D.8.r.6b -Indication (MedDRA code)
D.8.r.7a -MedDRA Version for Reaction
D.8.r.7b -Reaction (MedDRA code)
D.8.r -Relevant Past Drug History (repeat as necessary)
D.7.1.r.1a -MedDRA Version for Medical History
D.7.1.r.1b -Medical history (disease /surgical procedure /etc.) (MedDRA code)
D.7.1.r.2 -Start Date
D.7.1.r.3 -Continuing
D.7.1.r.4 -End Date
D.7.1.r.5 -Comments
D.7.1.r.6 -Family History
D.7.1.r -Structured Information on Relevant Medical History (repeat as necessary)
0 … 1
0 … n
0 … n
1 … 1
D.9.2.r.1a -MedDRA Version for Reported Cause(s) of Death
D.9.2.r.1b -Reported Cause(s) of Death (MedDRA code)
D.9.2.r.2 -Reported Cause(s) of Death (free text)
D.9.2.r -Reported Cause(s) of Death (repeat as necessary)
0 … n
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ICH ICSR Implementation Guide 12 April 2013
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D -Patient Characteristics
D.1 -Patient (name or initials)
D.1.1.1 -Patient Medical Record Number(s) and the Source(s) of the Record Number (GP Medical Record Number)
D.1.1.2 -Patient Medical Record Number(s) and the Source(s) of the Record Number (Specialist Record Number)
D.1.1.3 -Patient Medical Record Number(s) and the Source(s) of the Record Number (Hospital Record Number)
D.1.1.4 -Patient Medical Record Number(s) and the Source(s) of the Record Number (Investigation Number)
D.3 -Body Weight (kg)
D.4 -Height (cm)
D.5 -Sex
D.6 -Last Menstrual Period Date
D.7.2 -Text for Relevant Medical History and Concurrent Conditions (not including reaction /event)
D.7.3 -Concomitant Therapies
D.9.1 -Date of Death
D.9.3 -Was Autopsy Done?
D -Patient Characteristics
D.2.1 -Date of Birth
D.2.2a -Age at Time of Onset of Reaction /Event (number)
D.2.2b -Age at Time of Onset of Reaction /Event (unit)
D.2.2.1a -Gestation Period When Reaction /Event Was Observed in the Foetus (number)
D.2.2.1b -Gestation Period When Reaction /Event Was Observed in the Foetus (unit)
D.2.3 -Patient Age Group (as per reporter)
D.2 -Age Information
D.8.r.1 -Name of Drug as Reported
D.8.r.2a -MPID Version Date /Number
D.8.r.2b -Medicinal Product Identifier (MPID)
D.8.r.3a -PhPID Version Date /Number
D.8.r.3b -Pharmaceutical Product Identifier (PhPID)
D.8.r.4 -Start Date
D.8.r.5 -End Date
D.8.r.6a -MedDRA Version for Indication
D.8.r.6b -Indication (MedDRA code)
D.8.r.7a -MedDRA Version for Reaction
D.8.r.7b -Reaction (MedDRA code)
D.8.r -Relevant Past Drug History (repeat as necessary)
D.7.1.r.1a -MedDRA Version for Medical History
D.7.1.r.1b -Medical history (disease /surgical procedure /etc.) (MedDRA code)
D.7.1.r.2 -Start Date
D.7.1.r.3 -Continuing
D.7.1.r.4 -End Date
D.7.1.r.5 -Comments
D.7.1.r.6 -Family History
D.7.1.r -Structured Information on Relevant Medical History (repeat as necessary)
0 … 1
0 … n
0 … n
1 … 1
D.9.2.r.1a -MedDRA Version for Reported Cause(s) of Death
D.9.2.r.1b -Reported Cause(s) of Death (MedDRA code)
D.9.2.r.2 -Reported Cause(s) of Death (free text)
D.9.2.r -Reported Cause(s) of Death (repeat as necessary)
0 … n
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