What is the difference between Psur and DSUR?
The Development Safety Update Report (DSUR) is used for drugs still under development to assess risk to the subjects enrolled in the study, while the Periodic Safety Update Report (PSUR) is used for drugs already on the market to assess long-term safety.
What is the reporting period for a DSUR?
Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
What should I include in DSUR?
The DSUR should be accompanied by the following appendices, as appropriate, numbered as follows:
- Investigators Brochure;
- Cumulative Table of Important Regulatory Requests;
- Status of Ongoing and Completed Trials;
- Cumulative Summary Tabulations of Demographic Data;
- Line Listings of Serious Adverse Reactions;
What is a DSUR report?
DSURs are new, internationally-harmonized, safety documents (which became mandatory in European Union member states in September 2011) covering the safety summary of medicinal products during their development or clinical trial phase.
Is DSUR same as annual report?
Generally, the contents of a DSUR and annual report are fairly similar (as outlined above). However, the DSUR tends to be a little more detailed in its data analysis and has a slightly stronger focus on potential impacts on patients.
Who do you submit DSUR to?
1). The decision must be documented in the TMF. The DSUR will be submitted to both the MHRA and REC by the Sponsor. For trials where the DSUR submission responsibilities are delegated to another organisation or to the trial team, a final signed copy must be sent to the Sponsor.
When should a DSUR be submitted?
The DSUR should be submitted to all concerned regulatory agencies no later than 60 calendar days after the DSUR data lock point.
Where is DSUR submitted?
The sponsor is required to ensure that each year a Development Safety Update Report (DSUR) on the medicinal product is submitted to the reviewing committee (MREC or CCMO) and the competent authority (CCMO or Ministry of Health, Welfare and Sport).
Who is responsible for submission of DSUR?
The final signed DSUR, short-format DSUR or “No Patients Recruited Letter” will be submitted to the regulatory competent authority by the KHP-CTO CRA or delegate, as per their requirements, no later than 60 days after the Data Lock Point.