Serious?
If serious, please complete a JRO SAE form
Con-comitant Medication given
Severity
0 - Mild
1- Mode-rate
2 - Severe
Study Drug Action
0 - None
1 - Temporarily Interrupted
2 - permanently withdrawn
Outcome
0 - Resolved
1- Resolved with sequelea
2 - Not resolved
Relationship to
Study Drug
0 - Definitely
1 - Probably
2 - Possibly
3 - Unlikely
4 - Not related
5 - Not assessable
____/____/____
____/_____/____
No
Yes
No
Yes
____/_____/____
____/_____/____
No
Yes
No
Yes
____/_____/____
____/_____/____
No
Yes
No
Yes
____/_____/____
____/_____/____
No
Yes
No
Yes
____/_____/____
____/_____/____
No
Yes
No
Yes
____/_____/____
____/_____/____
No
Yes
No
Yes
I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, it accurately reflects the study information obtained for this participant
PI signature _______________________________ _________________ Date:_________________________ Please check box if this is the last page used
ADVERSE EVENTS PAGE(continuation page)
AE No
Event Name
(Please give Diagnosis if known)
Start date
(DD/MMM/YYYY)
Stop date(DD/MMM/YYYY)
Serious?
If serious, please complete a JRO SAE form
Concomitant Medication given
Severity
0 - Mild
1- Mode-rate
2 - Severe
Study Drug Action
0 - None
1 - Temporarily Interrupted
2 - permanently withdrawn
Outcome
0 - Resolved
1- Resolved with sequelea
2 - Not resolved
Relationship to
Study Drug
0 - Definitely
1 - Probably
2 - Possibly
3 - Unlikely
4 - Not related
5 - Not assessable
__
____/____/____
____/_____/____
No
Yes
No
Yes
__
____/_____/____
____/_____/____
No
Yes
No
Yes
__
____/_____/____
____/_____/____
No
Yes
No
Yes
__
____/_____/____
____/_____/____
No
Yes
No
Yes
__
____/_____/____
____/_____/____
No
Yes
No
Yes
__
____/_____/____
____/_____/____
No
Yes
No
Yes
I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, it accurately reflects the study information obtained for this participant
PI signature_______________________________ Date:_________________________ Please check box if this is the last page used
Concomitant Medications LOG
Has the participant used any Concomitant Medications? No Yes,Complete below
CM No.
Medication name
(Record <specify Generic or Brand> name)
Start date
(DD/MMM/YYYY)
Stop date(DD/MMM/YYYY)
Or tick if ongoing at end of study?
Reason for use
(Enter related AE diagnosis, or other reasons for use, e.g. Prophylaxis)
Dose
(Units)
Route
Frequency
1.
____/_____/_____
____/_____/_____
2.
____/_____/_____
____/_____/_____
3.
____/_____/_____
____/_____/_____
4.
____/_____/_____
____/_____/_____
5.
____/_____/_____
____/_____/_____
6.
____/_____/_____
____/_____/_____
7.
____/_____/_____
____/_____/_____
Please check box if this is the last page used
Note: Use the Concomittent log to record Non-IMPs
Concomitant Medications LOG(CONTINUATION PAGE)
CM No.
Medication name
(Record Generic name)
Start date
(DD/MMM/YYYY)
Stop date(DD/MMM/YYYY)
Or tick if ongoing at end of study?
Reason for use
(Enter related AE diagnosis, or other reasons for use, e.g. Prophylaxis)
Dose
(Units)
Route
Frequency
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
__.
____/_____/_____
____/_____/_____
Please check box if this is the last page used
PRINICIPAL INVESTIGATOR’S SIGN OFF
Principal Investigator’s Signature Statement:
I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study information obtained for this participant. All entries were made either by me or by a person under my supervision who has signed the Delegation and Signature Log.
Principal Investigator’s Signature:
__________________________________
Principal Investigator’s Name:
________________________________________
Date of Signature:
__ __/ __ __ __ / __ __ __ __
(DD / MMM / YYYY)
ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF WITHOUT A SIGNED DATA QUERY FORM.
