UCL Research Incidents Draft 1.0
REPORTING ADVERSE EVENTS AND INCIDENTS IN UCL SPONSORED STUDIES

When to use this form -
 
This form should NOT be used to report events in UCL sponsored studies which are managed by  

CRUK UCL Cancer Trials Centre 
PRIMENT
UCL Comprehensive Trials Unit 
UCL Surgical Trials Unit 

For other studies sponsored by UCL, the following should be reported using this form: 

1.  Incidents where an incident is

EITHER something which should have happened in a study but did not OR happened but should not have happened which significantly effects

a. the rights or well being of a research subject
b. the scientific value of the study
c. the compliance of the study with all relevant legal rules or ethics guidance including the Data Protection Act or the Human Tissue Act
d. UCL's reputation

2. Serious Adverse Events (SAE) in studies other  than Clinical Trials of Investigations Medicinal Products 

3Serious Adverse Devices Events (SDAE) in Devices Trials


4. Breaches of the study protocol 

5. Breaches of GCP if applicable

CONTACT DETAILS
Name of person completing the form
 
Please provide an email address through which you can be contacted

Contact phone number

ABOUT THE INCIDENT
When did the incident happen ? dd/mm/yyyy
If you can not provide a precise date, please provide a date when you first became aware of the incident
 
Where did the incident happen ?
 eg Whittington Hospital, OPD
What happened ? 
Please describe what happened in this Incident
What actions did you or research team take as result of the incident ?

Have you made any changes to the study or its conduct to prevent a re occurrence ?

Was any research participant harmed as a result of the incident ?
Is this incident
a serious adverse event  
a breach of protocol  
a breach of GCP, if applicable  
a Data Protection breach  
a breach of the Human Tissue Act  
If the study is a Clinical Trial of Investigational Medicinal Product (CTIMP) then you MUST also report any SAE, breaches or GCP or protocol to Trial Unit managing the study.
ABOUT THE STUDY
R and D Number  :
 

Research Ethics Committee number 

Who is Principal Investigator for the study ?
Study title ?