Small-scale early-phase trials (n < 50) may request a limited waiver for certain non-critical fields (e.g., genomic data flags), but the core audit trail and AE modules are always mandatory.
To pass an audit for Protocol 4.2.4, the following documentation must be present and error-free: aact 4.2.4
Even the best software encounters glitches. Here are the top three issues users report with AACT 4.2.4 and how to resolve them. Small-scale early-phase trials (n < 50) may request
Symptom: The software launches but disconnects after 10 minutes. This is common in classroom networks with aggressive firewall rules. Solution: Whitleist the following ports in your firewall: TCP 27000-27009 and TCP 2080. Also, ensure your system clock is synchronized with an NTP server—license validation is time-sensitive. To pass an audit for Protocol 4
If you are still using version 4.1 or older, you are operating with a handicap. Here is why upgrading to AACT 4.2.4 is essential for your shop or classroom.
Under AACT 4.2.4, every submission package must adhere to a strict naming convention:
The root directory must contain a manifest.aact file listing all included modules and their checksums.