ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
60
General timespan for multi-centre studies (max nr days)
60
ATMP/GMO trials (max nr days)
90
External expert advice required: Timespan (max nr days)
180
Xenogeneic cell therapy: Timespan (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of submission of valid application
Applicable national legal framework/ Reference
Section 53 (9&10) Act on Pharmaceuticals
Section 5 (5) Decree on GCP
KLH-11: Guideline on EC (Translation of Chapter 3. of ICH Guideline for Good Clinical Practice (E6, May 1, 1996))
Additional Information
There are set dates for EC meetings about once a month. Deadline for submission is usually about 20 days prior to the meeting.
The EC provide its opinion to the sponsor and to CA.
For more detailed info see Guidance “KLH-EC-01 – Application for Ethics Committee opinion on the conduct of a clinical trial in the Czech Republic”
