Infovert Technologies - R2 R3 Conversion

MedDRA LLT

Start Date

:

Continuing

End Date

:

Comments

0 characters out of 100

Disease/Procedure LLT

Start Date

:

Continuing

End Date

:

Comments

0 characters out of 100

Family History

This tool helps you visualize the changes a case will undergo when converting from R2 to R3 (and vice versa).

We have all seen the PDFs and spreadsheet that list out the conversion path from R2 to R3, but a picture is worth a thousand words. Hence, the the creation of this interactive tool.

In this tool, a case has been segmented into tabs or sections. These tabs follow the groupings found in the R2 and R3 specifications. While the tool is fairly easy to use, there is a small tutorial video that may be helpful.

Some points to bear in mind as you navigate though this tool:

While you have to select MedDRA codes when filling a case out, we have simulated MedDRA and used fictitious codes.
To keep the interface simple, we have ignored data elements whose value can be deduced or derived (such as date formats or asking for MedDRA version multiple times).
While cases can be submitted in batches, we have focused on individual cases when showing the R2 to R3 mapping.
In the same vein, we have (for now) ignored the conversion between R2 Acknowledgement file and R3 Acknowledgement file.
For most people, R2 to R3 conversion will be a one-time, one-way transaction.
Here, you can flip back and forth between R2 and R3, and see what the differences are and the impact on your data. Due to this reason, there are changes that we have listed under "R2/R3 Conversion" but not implemented.
For example, there are occasions where text should be appended to the Narrative. However, we have not done that since flipping back and forth between R2 and R3 may result in multiple copies of the same text being appended to the Narrative.
For consistency of data, we have created dropdowns for "Pharmaceutical Dose Form" and "Routes of Administration". While freeform text is allowed in R3, most companies would standardise their lists and manage them.

Infovert Technologies has had experience creating a validated enterprise level AE tracking system for both R2 and R3 specifications.
You can reach us at 1-416-801-0725 or pv.projects@infovert.com.

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Safety Report Version Number			Not applicable	Not applicable
Safety Report Unique Identifier	A.1.0.1	C.1.1	Copy as-is	Copy as-is
Country of the primary source	A.1.1		Not applicable	Copy from R3:C.2.r.3 {Country of Reporter} where R3:C.2.r.5 {Primary Source for Regulatory Purposes} is checked [Not Implemented]
Country where Reaction/Event occurred	A.1.2		Copy to R3:E.i.9 {Country where reaction occurred} for every Reaction [Not Implemented]	Copy from R3:E.i.9 {Country where reaction occurred} for the first reaction Reaction that has country selected. [Not Implemented]
Transmission Date	A.1.3b	C.1.2	Populated in XML as current date	Populated in XML as current date & time
Type of Report	A.1.4	C.1.3	Copy as-is	Copy as-is
Serious	A.1.5.1		Not applicable	Set to Yes if any Reaction has a {Seriousness criteria} (R3:E.i.3.2a to E.i.3.2f) checked [Not Implemented]
Resulted in death	A.1.5.2		Copied into R2:A.1.5.2 {Seriousness criteria} for every Reaction {Seriousness criteria} (R3: E.i.3.2a to E.i.3.2f) where checked [Not Implemented]	Set to checked for any {Seriousness criteria} (R3: E.i.3.2a to E.i.3.2f) checked for any Reaction [Not Implemented]
Life threatening	A.1.5.2
Caused/prlonged hospitalization	A.1.5.2
Disabling/incapacitating	A.1.5.2
Congenital anomaly/Birth defect	A.1.5.2
Other medically importat condition	A.1.5.2
Date report was first received from source	A.1.6b	C.1.4	Copy as-is	Copy as-is
Date of receipt of the most recent information for this report	A.1.7b	C.1.5	Copy as-is	Copy as-is
Are additional documents available	A.1.8.1	C.1.6.1	Match on text: true = Yes false = No	Match on text: 1 = Yes 2 = No
Does this case fulfill the local criteria for an expedited report?	A.1.9	C.1.7	Match on text: true = Yes false = No	Match on text: 1 = Yes 2 = No
Case medically confirmed?	A.1.14		Not applicable	Not applicable
Nullification/Amendment?	A.1.13	C.1.11.1	Match on value: 0=Original Submission 1=Nullification	Match on value for Original Submission and Nullification. If Amendment, add to Narrative [Not Implemented]
Nullification Reason	A.1.13.1	C.1.11.2	Copy as-is	If nullification, copy first 200 characters. Write entire text to Narrative for Nullification and Amendment [Not Implemented].
Amendment Reason		C.1.11.2	Not applicable	Add to Narrative [Not Implemented]
[Duplicate Reports]:Source	A.1.11.1	C.1.9.1.r.1	Copy as-is	Only the first 50 characters are copied
[Duplicate Reports]:Case Identifier	A.1.11.2	C.1.9.1.r.2	Copy as-is	Copy as-is
[Linked Reports]: Report/Case Number	A.1.12	C.1.10.r	Copy as-is	Copy as-is

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
[Reporter]: Title	A.2.1.1a	C.2.r.1.1	Copy as-is	Copy as-is
[Reporter]: Given Name	A.2.1.1b	C.2.r.1.2	Copy as-is	Only the first 35 characters are copied
[Reporter]: Middle Name	A.2.1.1c	C.2.r.1.3	Copy as-is	Only the first 15 characters are copied
[Reporter]: Family Name	A.2.1.1d	C.2.r.1.4	Copy as-is	Only the first 50 characters are copied
[Reporter]: Organization	A.2.1.2a	C.2.r.2.1	Copy as-is	Copy as-is
[Reporter]: Department	A.2.1.2b	C.2.r.2.2	Copy as-is	Copy as-is
[Reporter]: Street	A.2.1.2c	C.2.r.2.3	Copy as-is	Copy as-is
[Reporter]: City	A.2.1.2d	C.2.r.2.4	Copy as-is	Copy as-is
[Reporter]: Country	A.2.1.3	C.2.r.3	Copy as-is	Copy as-is. Populate R2:A.1.1 {Country of the primary source} if R3:C.2.r.5 {Primary Source for Regulatory Purposes} is checked [Not Implemented]
[Reporter]: State/Province	A.2.1.2e	C.2.r.2.5	Copy as-is	Copy as-is
[Reporter]: Zip/Postal Code	A.2.1.2f	C.2.r.2.6	Copy as-is	Copy as-is
[Reporter]: Telephone		C.2.r.2.7	Telephone will be blank	Not applicable
[Reporter]: Qualification	A.2.1.4	C.2.r.4	Copy as-is	Copy as-is
[Reporter]: Primary Source for Regulatory Purposes		C.2.r.5	Checkbox will be checked for the first Primary Source	Not applicable
[Reporter]: Reporter confidential?			Copy as-is	Copy as-is
[Literature]: Title	A.2.2	C.4.r.1	Copy as-is. Assembed as Vancouver citation, and the first 500 chars are sent to XML.	Copy as-is. Assembed as Vancouver citation, and the first 500 chars are sent to XML.
[Literature]: Author	A.2.2	C.4.r.1
[Literature]: Journal	A.2.2	C.4.r.1
[Literature]: Year	A.2.2	C.4.r.1
[Literature]: Volume	A.2.2	C.4.r.1
[Literature]: Issues	A.2.2	C.4.r.1
[Literature]: Pages	A.2.2	C.4.r.1
[Literature]: Document		C.4.r.2	Not applicable	Not applicable
[Study]: Study Name	A.2.3.1	C.5.2	Copy as-is	Only the first 100 characters are copied. If truncated, add to Narrative [Not Implemented]
[Study]: Sponsor Study Number	A.2.3.2	C.5.3	Copy as-is	Only the first 35 characters are copied. If truncated, add to Narrative [Not Implemented]
[Study]: Study Type	A.2.3.3	C.5.4	Copy as-is	Copy as-is
[Study Registration]: Study Registration Number		C.5.1.r.1	Not applicable	Not applicable
[Study Registration]: Study Registration Country		C.5.1.r.2	Not applicable	If space, copy as prefix to R2:A.2.3.1 {Study name} [Not Implemented]

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
[Sender]: Type	A.3.1.1	C.3.1	Copy as-is	If "Patient" in R3, set to "Other" in R2, else copy as-is
[Sender]: Message Sender Identifier	M.1.5	N.2.r.2	Copy as-is	Copy as-is
[Sender]: Organization	A.3.1.2	C.3.2	Copy as-is	Only the first 60 characters are copied.
[Sender]: Department	A.3.1.3a	C.3.3.1	Copy as-is	Copy as-is
[Sender]: Title	A.3.1.3b	C.3.3.2	Copy as-is	Only the first 10 characters are copied.
[Sender]: Given Name	A.3.1.3c	C.3.3.3	Copy as-is	Only the first 35 characters are copied.
[Sender]: Middle Name	A.3.1.3d	C.3.3.4	Copy as-is	Only the first 15 characters are copied.
[Sender]: Family Name	A.3.1.3e	C.3.3.5	Copy as-is	Only the first 35 characters are copied.
[Sender]: Street Address	A.3.1.4a	C.3.4.1	Copy as-is	Copy as-is
[Sender]: City	A.3.1.4b	C.3.4.2	Copy as-is	Copy as-is
[Sender]: Country	A.3.1.4e	C.3.4.5	Copy as-is	Copy as-is
[Sender]: State/PRovince	A.3.1.4c	C.3.4.3	Copy as-is	Copy as-is
[Sender]: Zip/Postal code	A.3.1.4d	C.3.4.4	Copy as-is	Copy as-is
[Sender]: Telephone	A.3.1.4f	C.3.4.6	Copy as-is	Only the first 10 characters are copied.
[Sender]: Tel Extension	A.3.1.4g		Not applicable	Not applicable
[Sender]: Tel Country code	A.3.1.4h		Not applicable	Not applicable
[Sender]: Fax	A.3.1.4i	C.3.4.7	Copy as-is	Only the first 10 characters are copied.
[Sender]: Fax Extension	A.3.1.4i		Not applicable	Not applicable
[Sender]: Fax Country Code	A.3.1.4k		Not applicable	Not applicable
[Sender]: Email	A.3.1.4l	C.3.4.8	Copy as-is	Copy as-is
[Receiver]: Type	A.3.2.1		Not applicable	Not applicable
[Receiver]: Message Receiver Identifier	M.1.6	N.2.r.3	Copy as-is	Copy as-is
[Receiver]: Organization	A.3.2.2a		Not applicable	Not applicable
[Receiver]: Department	A.3.2.2b		Not applicable	Not applicable
[Receiver]: Title	A.3.2.2c		Not applicable	Not applicable
[Receiver]: Given Name	A.3.2.2d		Not applicable	Not applicable
[Receiver]: Middle Name	A.3.2.2e		Not applicable	Not applicable
[Receiver]: Family Name	A.3.2.2f		Not applicable	Not applicable
[Receiver]: Street Address	A.3.2.3a		Not applicable	Not applicable
[Receiver]: City	A.3.2.3b		Not applicable	Not applicable
[Receiver]: Country	A.3.2.3e		Not applicable	Not applicable
[Receiver]: State/PRovince	A.3.2.3c		Not applicable	Not applicable
[Receiver]: Zip/Postal code	A.3.2.3d		Not applicable	Not applicable
[Receiver]: Telephone	A.3.2.3f		Not applicable	Not applicable
[Receiver]: Tel Extension	A.3.2.3g		Not applicable	Not applicable
[Receiver]: Tel Country code	A.3.2.3h		Not applicable	Not applicable
[Receiver]: Fax	A.3.2.3i		Not applicable	Not applicable
[Receiver]: Fax Extension	A.3.2.3j		Not applicable	Not applicable
[Receiver]: Fax Country Code	A.3.2.3k		Not applicable	Not applicable
[Receiver]: Email	A.3.2.3l		Not applicable	Not applicable

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Patient Initial	B.1.1	D.1	Copy as-is	Only the first 10 characters are copied.
Patient Masked?			Not part of the XML. Forces patient identifiable data to have value "PRIVACY"	Not part of the XML. Forces patient identifiable data to have value "PRIVACY"
GP Medical Record Number	B.1.1.1a	D.1.1.1	Copy as-is	Copy as-is
Specialist Record Number	B.1.1.1b	D.1.1.2	Copy as-is	Copy as-is
Hospital Record Number	B.1.1.1c	D.1.1.3	Copy as-is	Copy as-is
Investigation Number	B.1.1.1d	D.1.1.4	Copy as-is	Copy as-is
Date of Birth	B.1.2.1	D.2.1	Copy as-is	Copy date. Ignore time, if present.
Age at Reaction	B.1.2.2a	D.2.2a	Copy as-is	Copy as-is
Age at Reaction unit	B.1.2.2b	D.2.2b	Match on text: 10.a=Decade (UCUM code changed from {decade}) a=Year mo=Month wk=Week d=Day h=Hour	Match on text: 800 = Decade 801=Year 802=Month 803=Week 804=Day 805=Hour
Patient Age Group	B.1.2.3	D.2.3	Match on value: 0=Foetus 1=Neonate (Preterm and Term newborns) 2=Infant 3=Child 4=Adolescent 5=Adult 6=Elderly	If "Foetus", leave blank and set R2:B.1.1 {Patient initials} to "Foetus" if empty. [Not Implemented], else match on value: 1=Neonate 2=Infant 3=Child 4=Adolescent 5=Adult 6=Elderly
Weight (KG)	B.1.3	D.3	Copy as-is	Copy as-is
Weight (lb)	B.1.3	D.3	Calculated. Not part of XML	Calculated. Not part of XML
Height (cm)	B.1.4	D.4	Copy as-is	Copy as-is
Height (ft and inches)	B.1.4	D.4	Calculated. Not part of XML	Calculated. Not part of XML
Gender	B.1.5	D.5	Copy as-is (Value "Unknown" in implicit)	Copy as-is
Is patient a fetus?			Not part of the XML.	Not part of the XML.
Pregnant			Not part of the XML.	Not part of the XML.
Last Menstrual Period Date	B.1.6a	D.6	Copy as-is	Copy date. Ignore time, if present.
Gestation Period when reaction/event was observed in the fetus	B.1.2.2.1a	D.2.2.1a	Copy as-is	Copy as-is
Gestation Period when reaction/event was observed in the fetus unit	B.1.2.2.1b	D.2.2.1b	Match on text: mo=Month wk=Week d=Day {trimester}=Trimester	Match on text: 802=Month 803=Week 804=Day 810=Trimester
Patient died?			Not part of the XML.	Not part of the XML.
Date of death	B.1.9.1	D.9.1	Copy as-is	Copy as-is
[Reported cause of death]: Reported cause of death (MedDRA)	B.1.9.2.b	D.9.2.r.1b	Copy as-is	Copy as-is
[Reported cause of death]: Reported cause of death (free text)		D.9.2.r.2	Not applicable	Copy to R2:B.1.9.2.b {Reported cause(s) of death} if MedDRA code not provided.
Was autopsy done	B.1.9.3	D.9.3	Match on text: true= Yes false = No UNK = Unknown	Match on text: 1=Yes 2=No 3=Unknown
[Autopsy determined Cause of death]: Autopsy determined Cause of death (MedDRA)	B.1.9.4b	D.9.4.r.1b	Copy as-is	Copy as-is
[Autopsy determined Cause of death]: Autopsy determined Cause of death (free text)		D.9.4.r.2	Not applicable	Copy to R2:B.1.9.4.b {Autopsy-determined cause(s) of death} if MedDRA code not provided.

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Parent Initial	B.1.10.1	D.10.1	Copy as-is	Only the first 10 characters are copied.
Parent's date of birth	B.1.10.2.1	D.10.2.1	Update the Year, Month and date dropdowns	If only year, rest of date is Jan 1. If only year and month, day is the 1st.
Parent's age	B.1.10.2.2a	D.10.2.2a	Copy as-is	If 3 numbers, 99 comes across
Parent Age Unit	B.1.10.2.2b	D.10.2.2b	Copy as-is	If Decade is chosen, age is multipled by 10 to get years. This is the highest age in this decade (a person in their 50s is in their 6th decade, and 60 is the highest age in this decade)
Weight (kg)	B.1.10.4	D.10.4	Copy as-is	Copy as-is
Weight (lb)	B.1.10.4	D.10.4	Not part of the XML.	Not part of the XML.
Height (cm)	B.1.10.5	D.10.5	Copy as-is	Copy as-is
Height (ft and inches)	B.1.10.5	D.10.5	Not part of the XML.	Not part of the XML.
Gender	B.1.10.6	D.10.6	Copy as-is (Value "Unknown" in implicit)	Copy as-is
Last Mentstrual Period Date	B.1.10.3b	D.10.3	Update the Year, Month and date dropdowns	If only year, rest of date is Jan 1. If only year and month, day is the 1st.
[Parent Medical History]: MedDRA LLT	B.1.10.7.1a.2	D.10.7.1.r.1b	Copy as-is	Copy as-is
[Parent Medical History]: Start Date	B.1.10.7.1b	D.10.7.1.r.2	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Parent Medical History]: Continuing	B.1.10.7.1d	D.10.7.1.r.3	Match on text: true= Yes false = No UNK = Unknown	Match on text: 1=Yes 2=No 3=Unknown
[Parent Medical History]: End Date	B.1.10.7.1e	D.10.7.1.r.4	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Parent Medical History]: Comments	B.1.10.7.1g	D.10.7.1.r.5	Copy as-is	Only the first 100 characters are copied. If truncated, add to Narrative with header "PARENT MEDICAL HISTORY" [Not Implemented]
Relevant Medical History and Concurrent Conditions of Parent	B.1.10.7.2	D.10.7.2	Copy as-is	Copy as-is
[Parent Past Drug Therapy]: Drug Name	B.1.10.8a	D.10.8.r.1	Copy as-is	Only the first 100 characters are copied. R2:B.1.10.8a {Name of drug} is prefixed with (R3:D.10.8.r.2a and R3:D.10.8.r.2b {MPID}) or (R3:D.10.8.r.3a and R3:D.10.8.r.3b {PhPID}) [Not Implemented] If truncated, add to Narrative with header "PARENT DRUG HISTORY" [Not Implemented]
[Parent Past Drug Therapy]: MPID Version Date / Number		D.10.8.r.2a	Not applicable	Add to R2:B.1.10.8a {Name of drug} as prefix [Not Implemented]
[Parent Past Drug Therapy]: Medicinal Product Identifier (MPID)		D.10.8.r.2b	Not applicable	Add to R2:B.1.10.8a {Name of drug} as prefix [Not Implemented]
[Parent Past Drug Therapy]: PhPID Version Date / Number		D.10.8.r.3a	Not applicable	Add to R2:B.1.10.8a {Name of drug} as prefix [Not Implemented]
[Parent Past Drug Therapy]: Pharmaceutical Product Identifier (PhPID)		D.10.8.r.3b	Not applicable	Add to R2:B.1.10.8a {Name of drug} as prefix [Not Implemented]
[Parent Past Drug Therapy]: Start Date	B.1.10.8c	D.10.8.r.4	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Parent Past Drug Therapy]: End Date	B.1.10.8e	D.10.8.r.5	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Parent Past Drug Therapy]: Indication LLT	B.1.10.8f.2	D.10.8.r.6b	Copy as-is	Copy as-is
[Parent Past Drug Therapy]: Reaction LLT	B.1.10.8g.2	D.10.8.r.7b	Copy as-is	Copy as-is

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
[Medical History]: Disease/Procedure LLT	B.1.7.1a.2	D.7.1.r.1b	Copy as-is	Copy as-is
[Medical History]: Start Date	B.1.7.1c	D.7.1.r.2	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Medical History]: Continuing	B.1.7.1d	D.7.1.r.3	Match on text: true= Yes false = No UNK = Unknown	Match on text: 1=Yes 2=No 3=Unknown
[Medical History]: End Date	B.1.7.1f	D.7.1.r.4	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Medical History]: Comments	B.1.7.1g	D.7.1.r.5	Copy as-is	Only the first 100 characters are copied. If truncated, add to Narrative with header "MEDICAL HISTORY" [Not Implemented]
[Medical History]: Family History		D.7.1.r.6	Not applicable	Not applicable
Relevant Medical History and Concurrent Conditions	B.1.7.2	D.7.2	Copy as-is	Copy as-is
Concomitant Therapies		D.7.3	Not applicable	Not applicable

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Drug Name	B.1.8a	D.8.r.1	Copy as-is	Only the first 100 characters are copied. R2:B.1.8a {Name of drug} is prefixed with (R3:D.8.r.2a and R3:D.8.r.2b {MPID}) or (R3:D.8.r.3a and R3:D.8.r.3b {PhPID}) [Not Implemented] If truncated, add to Narrative with header "DRUG HISTORY" [Not Implemented]
MPID Version Date / Number		D.8.r.2a	Not applicable	Add to R2:B.1.8a {Name of drug} as prefix [Not Implemented]
Medicinal Product Identifier (MPID)		D.8.r.2b	Not applicable	Add to R2:B.1.8a {Name of drug} as prefix [Not Implemented]
PhPID Version Date / Number		D.8.r.3a	Not applicable	Add to R2:B.1.8a {Name of drug} as prefix [Not Implemented]
Pharmaceutical Product Identifier (PhPID)		D.8.r.3b	Not applicable	Add to R2:B.1.8a {Name of drug} as prefix [Not Implemented]
Start Date	B.1.8c	D.8.r.4	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
End Date	B.1.8e	D.8.r.5	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
Indication LLT	B.1.8f.2	D.8.r.6b	Copy as-is	Copy as-is
Reaction LLT	B.1.8g.2	D.8.r.7b	Copy as-is	Copy as-is

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Language of Report		E.i.1.1b	Not applicable	Not applicable
Reaction/Event reported in Native Language	B.2.i.0	E.i.1.1a	Not applicable	Copy first 200 characters. If truncated, add to Narrative under "REACTION/EVENT" [Not Implemented]
Reaction/Event reported		E.i.1.2	Copy as-is	Add to Narrative under "REACTION/EVENT" [Not Implemented].
Reaction MedDRA LLT	B.2.i.1.b	E.i.2.1b	Copy as-is	Copy as-is
Reaction MedDRA PT	B.2.i.2.b		Not applicable	Not applicable
Term Highlighted by Reporter	B.2.i.3	E.i.3.1	Match on value: 1=Yes, highlighted by the reporter, NOT serious 2=No, not highlighted by the reporter, NOT serious 3=Yes, highlighted by the reporter, SERIOUS 4=No, not highlighted by the reporter, SERIOUS	Match on value: 1=Yes, highlighted by the reporter, NOT serious 2=No, not highlighted by the reporter, NOT serious 3=Yes, highlighted by the reporter, SERIOUS 4=No, not highlighted by the reporter, SERIOUS
Results in Death		E.i.3.2a	Copied into R2: A.1.5.2 {Seriousness criteria} for every Reaction {Seriousness criteria} (R3: E.i.3.2a to E.i.3.2f) where checked [Not Implemented]	Set to checked R2:A.1.5.2 {Seriousness criteria} for any {Seriousness criteria} (R3: E.i.3.2a to E.i.3.2f) checked for any Reaction [Not Implemented]
Life Threatening		E.i.3.2b
Caused / Prolonged Hospitalisation		E.i.3.2c
Disabling / Incapacitating		E.i.3.2d
Congenital Anomaly / Birth Defect		E.i.3.2e
Other Medically Important Condition		E.i.3.2f
Start date of Reaction/Event	B.2.i.4b	E.i.4	Copy as-is	Copy as-is
End date of Reaction/Event	B.2.i.5b	E.i.5	Copy as-is	Copy as-is
Duration of Reaction/Event	B.2.i.6a	E.i.6a	Copy as-is	Copy as-is
Duration of Reaction/Event UNIT	B.2.i.6b	E.i.6b	Match ob text: a=Year mo=Month wk=Week d=Day h=Hour min=Minute s=Second	Match on text: 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 807=Second
Time interval between beginning of suspect drug administration and start of reaction/event	B.2.i.7.1a		R2 has this associated with Reaction and Drugs separately. The following R2 data elements will be assigned to R3 elements for Drug and Reaction, matching on Drug and Reaction Mimimum of (B.4.k.13.1a + B.4.k.13.1b for Drug A) and (B.2.i.7.1a + B.2.i.7.1a for Reaction B) to G.k.9.i.3.1a + G.k.9.i.3.1b for Drug A and Reaction B Mimimum of (B.4.k.13.2a + B.4.k.13.2b for Drug A) and (B.2.i.7.2a + B.2.i.7.2a for Reaction B) to G.k.9.i.3.2a + G.k.9.i.3.2b for Drug A and Reaction B [Not Implemented]	R3 has this asociated with Drug/Reaction combo. For the following R3 data elements, the shortest time interval for a Reaction and Drug combination will be assigned to R2 elements, matching on Reaction and on Drug Minimum G.k.9.i.3.1a + G.k.9.i.3.1b for Reaction B to B.2.i.7.1a + B.2.i.7.1b for Reaction B Minimum G.k.9.i.3.2a + G.k.9.i.3.2b for Reaction B to B.2.i.7.2a + B.2.i.7.2b for Reaction B Minimum G.k.9.i.3.1a + G.k.9.i.3.1b for Drug A to B.4.k.13.1a + B.4.k.13.1b for Drug A Minimum G.k.9.i.3.2a + G.k.9.i.3.2b for Drug A to B.4.k.13.2a + B.4.k.13.2b for Drug A [Not Implemented]
Time interval between beginning of suspect drug administration and start of reaction/event UNIT	B.2.i.7.1b
Time interval between last dose and start of reaction/event	B.2.i.7.2a
Time interval between last dose and start of reaction/event UNIT	B.2.i.7.2b
Outcome of reaction/event at time of last observation	B.2.i.8	E.i.7	Data will be mapped between R2 and R3: 1 = recovered/resolved 2 = recovering/resolving 3 = not recovered/not resolved/ongoing 4 = recovered/resolved with sequelae 5 = fatal 0 = unknown	Data will be mapped between R2 and R3: 1=recovered/resolved 2=recovering/resolving 3=not recovered/not resolved 4=recovered/resolved with sequelae 5=fatal 6=unknown
Medical Confirmation by Healthcare Professional		E.i.8	Not applicable	Not applicable
Identification of the Country Where the Reaction / Event Occurred		E.i.9	Copy from R2:A.1.2 {Country where the reaction occurred} for all events [Not Implemented]	Copy to R2:A.1.2 {Country where the reaction occurred} from the first reaction with a country selected.

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
[Test]: Test Date	B.3.1b	F.r.1	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Test]: Test Name		F.r.2.1	Not applicable	Not applicable
[Test]: Test Name MedDRA LLT	B.3.1c	F.r.2.2b	Copy as-is	Copy as-is
[Test]: Test Result (code)		F.r.3.1	Not applicable	Values are: 1=Positive 2=Negative 3=Borderline 4=Inconclusive Copy text to R2:B.3.1d {Test result} if R3:F.r.3.2 {Test Result (value/qualifier)} is empty, otherwise copy to R2:B.3.2 {Results of tests and procedures relevant to the investigation of the patient} [Not Implemented]
[Test]: Result (value / qualifier)	B.3.1d	F.r.3.2	Copied only if numeric, otherwise copied to R3:F.r.3.4 {Result Unstructured Data}	If empty, data is copied from R3:F.r.3.1 {Test Result (code)} [Not Implemented]. Otherwise, Copy as-is
[Test]: Result unit	B.3.1e	F.r.3.3	Copy as-is	Copy as-is
[Test]: Result Unstructured Data (free text)		F.r.3.4	Not applicable	Copy to R2:B.3.2 {Results of tests and procedures relevant to the investigation of the patient} [Not Implemented]
[Test]: Normal Low Range	B.3.1.1	F.r.4	Copy as-is	Copy as-is
[Test]: Normal High Range	B.3.1.2	F.r.5	Copy as-is	Copy as-is
[Test]: Comments (free text)		F.r.6	Not applicable	Copy all values of R3:F.r.1 {Test Date}, R3:F.r.2.1 {Test Name (free text)} and R3:F.r.3.4 {Result Unstructured Data} to R2:B.3.2 {Results of tests and procedures relevant to the investigation of the patient} [Not Implemented]
[Test]: More Information available	B.3.1.3	F.r.7	Match on text: true= Yes false = No	Match on text: 1=Yes 2=No
Results of tests and procedures relevant to the investigation of the patient	B.3.2		Copy to R3:F.r.3.4 {Result Unstructured Data} [Not Implemented]	If not done for R3:F.r.6, then copy all values of R3:F.r.1 {Test Date}, R3:F.r.2.1 {Test Name (free text)} and R3:F.r.3.4 {Result Unstructured Data}, if it fits Otherwise, add to Narrative as "TEST DATA" [Not Implemented]

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
[Drugs]: Drug Role	B.4.k.1	G.k.1	Copy as-is	Copy as-is for the first three choices. If role is "Drug Not Administered", append "Drug Not Administered" to R2:B.4.k.19 {Additional information on drug} [Not Implemented]
[Drugs]: MPID Version Date / Number		G.k.2.1.1a	Not applicable	Add to R2:B.4.k.2.1 {Medicinal product name} as prefix [Not Implemented]
[Drugs]: Medicinal Product Identifier (MPID)		G.k.2.1.1b	Not applicable	Add to R2:B.4.k.2.1 {Medicinal product name} as prefix [Not Implemented]
[Drugs]: PhPID Version Date / Number		G.k.2.1.2a	Not applicable	Add to R2:B.4.k.2.1 {Medicinal product name} as prefix [Not Implemented]
[Drugs]: Pharmaceutical Product Identifier (PhPID)		G.k.2.1.2b	Not applicable	Add to R2:B.4.k.2.1 {Medicinal product name} as prefix [Not Implemented]
[Drugs]: Proprietary Medicinal Product Name	B.4.k.2.1	G.k.2.2	Copy as-is	Only the first 70 chars are copied R2:B.4.k.2.1 {Medicinal product name} is prefixed with (R3:G.k.2.1.1a and R3:G.k.2.1.1b {MPID}) or (R3:G.k.2.1.2a and R3:G.k.2.1.2b {PhPID}) [Not Implemented]
[Drugs]: Country where drug was obtained	B.4.k.2.3	G.k.2.4	Copy as-is	Copy as-is
[Drugs]: Investigational Product Blinded		G.k.2.5	Not applicable	If checked, add "INVESTIGATION" to R2:B.4.k.19 {Additional information on drug} [Not Implemented]
[Drugs]: Authorization/Application Number	B.4.k.4.1	G.k.3.1	Copy as-is	Copy as-is
[Drugs]: Country of Authorization/Application	B.4.k.4.2	G.k.3.2	Copy as-is	Copy as-is
[Drugs]: Name of Holder/Applicant	B.4.k.4.3	G.k.3.3	Copy as-is	Copy as-is
[Drugs]: Number of separate dosages	B.4.k.5.3		Not applicable	Not applicable
[Drugs]: Cumulative dose to first reaction	B.4.k.5.6	G.k.5a	Copy as-is	Copy as-is
[Drugs]: Cumulative dose to first reaction units	B.4.k.5.7	G.k.5b	Match on text	Match on text
[Drugs]: Gestation period at Time of Exposure	B.4.k.10a	G.k.6a	Copy as-is	Copy as-is
[Drugs]: Gestation period at Time of Exposure unit	B.4.k.10b	G.k.6b	Match on text: mo=Month wk=Week d=Day {trimester}=Trimester	Match on text: 802=Month 803=Week 804=Day 810=Trimester
[Drugs]: Time Interval between Drug Administration and Start of Reaction/Event	B.4.k.13.1a		R2 has this associated with Reaction and Drugs separately. The following R2 data elements will be assigned to R3 elements for Drug and Reaction, matching on Drug and Reaction Mimimum of (B.4.k.13.1a + B.4.k.13.1b for Drug A) and (B.2.i.7.1a + B.2.i.7.1a for Reaction B) to G.k.9.i.3.1a + G.k.9.i.3.1b for Drug A and Reaction B Mimimum of (B.4.k.13.2a + B.4.k.13.2b for Drug A) and (B.2.i.7.2a + B.2.i.7.2a for Reaction B) to G.k.9.i.3.2a + G.k.9.i.3.2b for Drug A and Reaction B [Not Implemented]	R3 has this asociated with Drug/Reaction combo. For the following R3 data elements, the shortest time interval for a Reaction and Drug combination will be assigned to R2 elements, matching on Reaction and on Drug Minimum G.k.9.i.3.1a + G.k.9.i.3.1b for Reaction B to B.2.i.7.1a + B.2.i.7.1b for Reaction B Minimum G.k.9.i.3.2a + G.k.9.i.3.2b for Reaction B to B.2.i.7.2a + B.2.i.7.2b for Reaction B Minimum G.k.9.i.3.1a + G.k.9.i.3.1b for Drug A to B.4.k.13.1a + B.4.k.13.1b for Drug A Minimum G.k.9.i.3.2a + G.k.9.i.3.2b for Drug A to B.4.k.13.2a + B.4.k.13.2b for Drug A [Not Implemented]
[Drugs]: Time Interval between Drug Administration and Start of Reaction/Event UNIT	B.4.k.13.1b
[Drugs]: Time interval between last dose and start of reaction/event	B.4.k.13.2a
[Drugs]: Time interval between last dose and start of reaction/event UNIT	B.4.k.13.2b
[Drugs]: Action(S) Taken with Drug:	B.4.k.16	G.k.8	Match on text: 1=Drug withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 0=Unknown 9=Not applicable	Match on text: 1=Drug withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Unknown 6=Not applicable
[Drugs]: Additional Information (Coded)		G.k.10.r	Not applicable	Text added to R2:B.4.k.19 {Additional information on drug}. If not enough room, added to Narrative under "ADDITIONAL INFORMATION ON DRUG" [Not Implemented]
[Drugs]: Additional Information on drug	B.4.k.19	G.k.11	Copy as-is	Only the first 100 characters are copied. Also copied to Narrative under "ADDITIONAL INFORMATION ON DRUG", if larger than 100 characters [Not Implemented]
[Dosage Information]: Dose	B.4.k.5.1	G.k.4.r.1a	Formula: R2:B.4.k.5.1 {Dose} * (Maximum of R2:B.4.k.5.3 {Number of separate dosages} and 1)	Copy as-is
[Dosage Information]: Dose unit	B.4.k.5.2	G.k.4.r.1b	Match on text	MAtch on text
[Dosage Information]: Number of units in Interval	B.4.k.5.4	G.k.4.r.2	Copy as-is	If length of 3, copy as-is. Otherwise, copy to R2:B.4.k.6 {Dosage Text} [Not implemented]
[Dosage Information]: Interval units	B.4.k.5.5	G.k.4.r.3	Match on text: a=Year mo=Month wk=Week d=Day h=Hour min=Minute	Match on text: 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute If no match, copy to R2:B.4.k.6 {Dosage Text} [Not implemented]
[Dosage Information]: Drug Start Date	B.4.k.12b	G.k.4.r.4	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Dosage Information]: Date of Last Administration	B.4.k.14b	G.k.4.r.5	Copy as-is	Copy YYYY,MM,DD. Hours and minute (if present) are ignored
[Dosage Information]: Duration of Drug Administration	B.4.k.15a	G.k.4.r.6a	Copy as-is	Copy as-is
[Dosage Information]: Duration of Drug Administration UNIT	B.4.k.15b	G.k.4.r.6b	Match on text: a=Year mo=Month wk=Week d=Day h=Hour min=Minute	Match on text: 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute
[Dosage Information]: Batch/Lot Number	B.4.k.3	G.k.4.r.7	Copy as-is	Copy as-is
[Dosage Information]: Dosage Text	B.4.k.6	G.k.4.r.8	Copy as-is	Copy the first 100 characters
[Dosage Information]: Pharmaceutical Form	B.4.k.7	G.k.4.r.9.1	Copy as-is	Copy the first 50 characters
[Dosage Information]: Pharmaceutical Dose Form TermID Version Date / Number		G.k.4.r.9.2a	Not applicable	Not applicable
[Dosage Information]: Pharmaceutical Dose Form TermID		G.k.4.r.9.2b	Not applicable	Not applicable
[Dosage Information]: Route of Administration	B.4.k.8	G.k.4.r.10.1	Copy displayed text as-is	Copy code from R3:G.k.4.r.10.2b {Route of Administration TermID}. If R3:G.k.4.r.10.2b {Route of Administration TermID} not set, set to "050" (Other) [Not Implemented]
[Dosage Information]: Route of Administration TermID Version Date / Number		G.k.4.r.10.2a	Not applicable	Not applicable
[Dosage Information]: Route of Administration TermID		G.k.4.r.10.2b	Copy numeric code of Route	Copy code into R2:B.4.k.8 {Route of administration}
[Dosage Information]: Parent Route of Administration	B.4.k.9	G.k.4.r.11.1	Copy displayed text as-is	Copy code from R3:G.k.4.r.11.2b {Parent Route of Administration TermID}. If R3:G.k.4.r.11.2b {Parent Route of Administration TermID} not set, set to "050" (Other) [Not Implemented]
[Dosage Information]: Parent Route of Administration TermID Version Date / Number		G.k.4.r.11.2a	Not applicable	Not applicable
[Dosage Information]: Parent Route of Administration TermID		G.k.4.r.11.2b	Copy numeric code of Parent Route	Copy code into R2:B.4.k.9 {Parent route of administration}

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
[Active Substance]: Active Substance Name	B.4.k.2.2	G.k.2.3.r.1	Copy as-is	Copy the first 100 characters R2:B.1.8a {Name of Drug} is prefixed with (R3:G.k.2.3.r.2a and R3:G.k.2.3.r.2b {Active Substance TermID}) [Not Implemented] If truncated, add to Narrative with header "SUBSTANCE" [Not Implemented]
[Active Substance]: Active Substance TermID Version Date / Number		G.k.2.3.r.2a	Not applicable	Add to R2:B.4.k.2.2 {Active Drug substance names} as prefix [Not Implemented]
[Active Substance]: Active Substance/Specified Substance TermID		G.k.2.3.r.2b	Not applicable	Add to R2:B.4.k.2.2 {Active Drug substance names} as prefix [Not Implemented]
[Active Substance]: Strength (number)		G.k.2.3.r.3	Not applicable	Appended to R2:B.4.k.19 {Additional information on drug}
[Active Substance]: Strength (unit)		G.k.2.3.r.4	Not applicable	Appended to R2:B.4.k.19 {Additional information on drug}
[Drug Recurrence]: Reaction		G.k.9.i.1	Derived from Reaction list	Derived from Reaction list
[Drug Recurrence]: Did Reaction Recur on Readministration?	B.4.k.17.1	G.k.9.i.4	"Yes" is mapped to "yes-yes" "No" is mapped to "yes-no" "Unknown" is not mapped	"yes-yes" is mapped to "Yes" "yes-no" is mapped to "No" Everything else is mapped to "Unknown"
[Drug Recurrence]: Time Interval between Drug Administration and Start of Reaction/Event		G.k.9.i.3.1a	R2 has this associated with Reaction and Drugs separately. The following R2 data elements will be assigned to R3 elements for Drug and Reaction, matching on Drug and Reaction Mimimum of (B.4.k.13.1a + B.4.k.13.1b for Drug A) and (B.2.i.7.1a + B.2.i.7.1a for Reaction B) to G.k.9.i.3.1a + G.k.9.i.3.1b for Drug A and Reaction B Mimimum of (B.4.k.13.2a + B.4.k.13.2b for Drug A) and (B.2.i.7.2a + B.2.i.7.2a for Reaction B) to G.k.9.i.3.2a + G.k.9.i.3.2b for Drug A and Reaction B [Not Implemented]	R3 has this asociated with Drug/Reaction combo. For the following R3 data elements, the shortest time interval for a Reaction and Drug combination will be assigned to R2 elements, matching on Reaction and on Drug Minimum G.k.9.i.3.1a + G.k.9.i.3.1b for Reaction B to B.2.i.7.1a + B.2.i.7.1b for Reaction B Minimum G.k.9.i.3.2a + G.k.9.i.3.2b for Reaction B to B.2.i.7.2a + B.2.i.7.2b for Reaction B Minimum G.k.9.i.3.1a + G.k.9.i.3.1b for Drug A to B.4.k.13.1a + B.4.k.13.1b for Drug A Minimum G.k.9.i.3.2a + G.k.9.i.3.2b for Drug A to B.4.k.13.2a + B.4.k.13.2b for Drug A [Not Implemented]
[Drug Recurrence]: Time Interval between Drug Administration and Start of Reaction/Event UNIT		G.k.9.i.3.1b
[Drug Recurrence]: Time interval between last dose and start of reaction/event		G.k.9.i.3.2a
[Drug Recurrence]: Time interval between last dose and start of reaction/event UNIT		G.k.9.i.3.2b
[Indication]: Indication (MedDRA code)	B.4.k.11b	G.k.7.r.2b	Copy as-is	First indication is copied. The rest, if any are added, with the drug name, to Narrative under "DRUG INDICATIONS"
[Indication]: Indication as Reported by the Primary Source		G.k.7.r.1	Not applicable	Not applicable

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Product			Embedded in XML. Copy as-is	Embedded in XML. Copy as-is
Reaction	B.4.k.18.1b		Embedded in XML. Copy as-is	Embedded in XML. Copy as-is
Assessment Source	B.4.k.18.2	G.k.9.i.2.r.1	Copy as-is	Copy as-is
Assessment Method	B.4.k.18.3	G.k.9.i.2.r.2	Copy as-is	Only first 35 characters are copied.
Assessment Result	B.4.k.18.4	G.k.9.i.2.r.3	Copy as-is	Only first 35 characters are copied.

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Case Narrative	B.5.1	H.1	Copy as-is	Only the first 20,000 characters are copied.
Reporter's Comment	B.5.2	H.2	Copy as-is	Only the first 500 characters are copied. If truncated, add to Narrative under "REPORTER COMMENTS" [Not Implemented]
Sender's Diagnosis LLT (textbox in R2, grid in R3)	B.5.3b	H.3.r.1b	Copy as-is (becomes first row of Diagnosis grid)	Copy as-is in the first row of the Diagnosis grid. If more than one Diagnosis LLT, add to Narrative under "SENDER DIAGNOSIS" [Not Implemented]
Senders Comments	B.5.4	H.4	Copy as-is	Only the first 2000 characters are copied. If truncated, add to Narrative under "SENDER COMMENTS" [Not Implemented]
[Grid]: Case Summary and Reporter’s Comments Text		H.5.r.1a	Not applicable	Add to Narrative under "CASE SUMMARY" [Not Implemented]
[Grid]: Case Summary and Reporter’s Comments Language		H.5.r.1b	Not applicable	Not applicable

Data Element	R2 ID	R3 ID	R2 → R3	R3 → R2
Document Name	A.1.8.2	C.1.6.1.r.1	Copy as-is	Only the first 100 characters are copied. If truncated, add to Narrative under "ADDITIONAL DOCUMENTS" [Not Implemented]
Document		C.1.6.1.r.2	Not applicable	Not applicable

Queston	Yes	No	Don't know
Are there previous conclusive reports on this reaction?	(+1)	(0)	(0)
Did the adverse event appear after the suspected drug was administered?	(+2)	(-1)	(0)
Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?	(+1)	(0)	(0)
Did the adverse event reappear when the drug was re-administered?	(+2)	(-1)	(0)
Are there alternative causes (other than the drug) that could on their own have caused the reaction?	(-1)	(+2)	(0)
Did the reaction reappear when a placebo was given?	(-1)	(+1)	(0)
Was the drug detected in blood (or other fluids) in concentrations known to be toxic?	(+1)	(0)	(0)
Was the reaction more severe when the dose was increased or less severe when the dose was decreased?	(+1)	(0)	(0)
Did the patient have a similar reaction to the same or similar drugs in any previous exposure?	(+1)	(0)	(0)
Was the adverse event confirmed by any objective evidence?	(+1)	(0)	(0)

Total score: 0 Doubtful, 1-4 Possible, 5-8 Probable, > 8 Definite

Result : Doubtful

Assessment not updated with Result in demo

The time between the drug administration and the occurrence of an adverse event.
Absence of other causes like concomitant medications and current disease.
Response to drug withdrawal or drug dose reduction (dechallenge).
Response to drug administration after dechallenge (rechallenge).