Clinical Trial Complaint Form ver 1 (SOP_020008)
A complaint should be raised in case of impaired product quality and issues related to the device, investigational medicinal product (IMP), and/or packaging.
In the event of a complaint, fill in the form below with available information. Please include as much information as possible to ensure correct and proper handling of the issue.
If you have any questions e.g. whether a complaint should be raised or how to complete the form, please email prior to submitting the form to Drug Safety (email on page 2).
Trial Site InformationTrial Site Number
Investigator
(name, initials, email)
Country
Complaint Details
Trial ID
Subject ID / Randomisation Number
Kit Number
Batch Number
Expiry date
Homeuse / Yes No
Description of the event
Date of event / (DD/MM/YYYY):
Detailed description of the complaint issue or defect
Guiding Questions
- What happened?
- How/why did the issue/defect occur?
- When was the issue/defect noticed (i.e. during inspection, administration etc.?)
- Were the handling instructions read and followed?
- Were there any signs of package damage?
Complaint is evaluated to be critical
Critical product complaintis defined as an issue, defect, or device deficiency that has or potentially could have a serious impact for the subject (e.g. SAE or large particles in the syringe). / Yes No
If Yes/in doubt, please forward the complaint form to LEO Pharma within 24 hours.
If No, please forward the complaint form to LEO Pharma within 3 days.
Complaint Sample
Sample(s) available / Yes No
If Yes;
1)Ensure that the affected sample(s) are stored separately at labelled and monitored conditions. You will be notified whether the sample needs to be returned for further investigation or may be destructed.
2)Take photos of the affected sample. The photos should best capture the complaint issue, trial ID, and kit number. Forward the photos with the complaint form.
Adverse Events
Non-serious Adverse Event (AE) / Yes No
If Yes, please register the Non-serious AE in the clinical database.
Serious Adverse Event (SAE) / Yes No
If Yes, please register the SAE in the clinical database and report it to GPV on the SAE form (ENC_006804).
When all available information are filled in, please forward the complaint form, photos, and other evidence to
Once the complaint has been processed, a closure letter including a conclusion will be returned to the trial site.
To be filled at LEO PharmaComplaint received in GPV by / LEO ID:
Initial Leo Receipt date / DD/MM/YYYY:
AE/OE included / Yes No
MFR number: