All suspected ADRs must be reported to Initios Medical, independent of seriousness and if it is listed in the SPC or not. The reports will then be forward via Trial Form Support to Bracco/E-Z-EM who will report to the appropriate regulatory authorities.
To be considered a valid case report the information must include as a minimum of the following information:
• an identifiable patient (with at least one of the following information sex, age, birth
date or initials )
• an identifiable reporting source (reporter)
• an adverse reaction
• a suspected medicinal product
The report must be completed in English on a CIOMS I form. Please send the report at once to Initios Medical, fax +46 31 52 19 40 or to Trial Form Support (TFS), Clinical Drug Safety, fax +46 46 31 33 88. E-mail addresses info@initios.com or safety.tfs@trialformsupport.com.
The original report must be sent by ordinary mail to Initios Medical, Salsmästaregatan 32, 422 46 Hisings-Backa, Sweden.
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Checklist how to fill in a CIOMS I form
1. Patient initials
1a. Country
2. Patient date of birth
2a. Patient age
3. Patient sex (F=female, M=male)
4. Start date for the occurrence of the ADR
7+13. Descriptions of side effects/reactions, i.e. the cause, relationship between
administration of the medication and the ADR, results of relevant investigations and any consequence of the ADR which are not described under section 8-12, if applicable.
8-12. Consequences of the side effects
14. Suspected drug and if possible the batch number
15. Dose of the suspected drug
16. Rout of administration (e.g. oral, intravenous)
17. Indication for use
18. Therapy dates
19. Therapy duration
20. Did the reaction abate after stopping drug (please state if this is not applicable)
21. Did the reaction reappear after reintroduction
22. Concomitant medication incl. start and stop date for treatment as well as if no other drugs have been given
23. Relevant medical history, i.e. earlier experience of side effects and risk factors
IV. Manufacturer Information, right box: Please state the physicians name, address,
telephone, fax no. or/and e-mail address as well as the name of the Initios employee who forward the report.
• Ask the physician to sign off and date the report!
• Please inform that we might ask for follow up information.
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