Topic: Protocol QC task to be accomplished in 2 days for FDA submission (against the usual 5 days)
Challenges:
Protocol with complex study design and multiple primary, secondary, and exploratory endpoints from Immunology TA spanning over 130 pages
Despite the very truncated timelines for QC (i.e., 2 days) the scope was comprehensive & spanned across all parameters - Content against source data, consistency between sections, grammar, formatting, references and style guide check
SIRO Solution:
Since the QC request was intimated well in advance, SIRO PM requested that during the drafting stage of the protocol it would be a good idea to allow the "frozen " sections for QC. The client agreed and some sections were QC'ed beforehand.
For the finalized document, the QC work was distributed section-wise amongst 3 MWs in the interest of time (this is usually not done to maintain consistency and uniformity of the QC by a single MW)
Comments were collated and discussed amongst the 3 MWs for consistency and appropriateness before delivery
MWs worked extended hours in order to meet the timeline
Key Takeaways:
SIRO suggested to the client that such short turnaround time QCs can be conducted in 2 stages.
This "Staged QC " can be extended to certain other document types where sections can be frozen earlier during the drafting.
SIRO was appreciated for this kind of a "different, innovative, and proactive approach " of QCs
