Castor Form Exchange | SAE form UMC Utrecht

1.1

METC or ABR Number

1.2

Study Title (short)

1.3

EudraCT Number (if applicable)

1.4

Year of birth of subject

An initial report must be sent to xxx xxx xxx within 24 hours after (investigator becomes aware of) the serious adverse event.

2.1

Date of report

2.2

Type of report

2.3

Name Principal Investigator (local)

2.4

Institute local Principal Investigator

2.5

Office phone local Principal Investigator

2.6

Fax local Principal Investigator

2.7

Email local Principal Investigator

2.8

Date of onset Serious Adverse Event

Brief description of Subject:

2.9

Gender of subject

2.10

Diagnosis subject

2.11

Event/Reaction

2.12

Describe event

2.13

Category of the serious adverse event

Relationship of serious adverse event to the investigational medicinal product, the investigational medical device or the investigational treatment:

2.14

What is being investigated?

2.15

Relationship of SAE to the investigational medicinal product/treatment of device

2.16

Was the event/reaction expected or unexpected?

Expected: the event is known, i.e. reported in earlier research as possibly related. Unexpected: the event is unknown, i.e. not reported in earlier research.

2.17

Action taken with investigational product or the experimental treatment

2.18

What is the outcome of the SAE

2.19

Date event resolved

2.20

Date patient died

2.21

Remarks

2.22

Did the person who completed the SAE report sign the paper SEA form?

2.23

Did the Principal Investigator sign the paper SAE form?

Report type

1: Initial

2: Follow-up

3: Final

Gender

1: Male

2: Female