Temporary halt and restart

Temporary halt

Article 2 (28) of the CTR defines the temporary halt of a clinical trial as an

"interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of sponsor to resume it."

The temporary halt of a clinical trial should be reported in CTIS within 15 days (art 37 CTR).

In case the temporary halt is for reasons of subject safety, then the sponsor should report this in CTIS without undue delay but not later than in 15 days. The reasons for such action should be included as well as the follow-up measures.

See also Question 10.4-10.6 of the Q&A CTR.

Restart of clinical trial

When the reasons for a temporary halt have had no potential effect on the benefit/risk balance, the sponsor should report in CTIS when the clinical trial is resumed within 15 days of the restart of the clinical trial (art 37 CTR).

In case the reasons for the temporary halt have the potential to affect the benefit/risk balance, the sponsor should request a restart of the clinical trial through a substantial modification (art 38 CTR).

If a temporarily halted clinical trial is not resumed within two years, the expiry date of this period shall be deemed to be the date of the end of the clinical trial. However, the sponsor can submit within the two-year period following a temporary halt a substantial modification requesting a restart date after the 2-year period.

See also Question 10.4-10.6 of the Q&A CTR.