Israel has its own clinical trials registry, Clinical Research Site – MyTrial. It is not a World Health Organization (WHO) recognized primary registry. It has a provision for posting the protocol registrations for studies conducted in Israel. The information to be posted to the registry should be in Hebrew. Posting protocol registration on MyTrial is a mandatory requirement, but there is no functionality for posting the results of the trials.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| Clinical Research Site – MyTrial | Mandatory National Database (includes Ethics Requirement) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional Phase 1-4; (except healthy volunteers) |
Hebrew |
| ClinicalTrials.gov | Country requiring/recommending ClinicalTrials.gov use | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional Phase 2-4 |
English |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| Clinical Research Site – MyTrial | Registration |
Yes |
Only after approval by the Ethics Committee; Before the start of the study |
| Results |
n/a |
Not Applicable (NA) | |
| ClinicalTrials.gov | Registration |
No |
Within 21 days of first patient enrollment |
| Results |
No |
Within one year of primary completion date (PCD); Within one year of the last subject last visit for each secondary outcome measure (SOM); Within one year of the study completion date | |
Registry Updates
- May 2022: CTIS Training Update - European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on May 25, 2022, by updating the below document in Module 16- Supervise a clinical trial: Inspection records: FAQs: Supervise a Clinical Trial and a Clinical Trial: Inspection records – Module 16: The questions and answers that are added or revised in … Continue reading "May 2022: CTIS Training Update"
- June 2017: Israel Registry Update - Clinical Research Site – MyTrial rolled out by Ministry of Health (MoH), Israel June 5, 2017: By the initiation of the Ministry of Health, a new site for Clinical Trial Database has been made available. The database provides information about clinical studies, which includes details of the disease/medical condition, the intervention examined, the manner in … Continue reading "June 2017: Israel Registry Update"
References
- Clinical Research Site – MyTrial. Clinical Research Site – MyTrial https://my.health.gov.il/CliniTrials/Pages/About.aspx. Published June 2017. Accessed June 2017.