Data Lock

Today we lock the database

Finally, data lock

I was brought on to this rescue study after conduct was complete; the other CRO had been fired and things were a total mess.  The final week was the longest yet, when I arrived on site there were still around 300 CRFs that had not been SDVd but luckily management sent in reinforcements. I was lucky enough to be joined by 2 excellent and experienced Senior CRAs and 1 very wonderful consultant CRA. It was a long week but the effort at my sites was extraordinary and we finished Thursday night ahead of schedule! We stayed late each night, I brought in lunch and caffeine so breaks were kept to a minimum, and I ran a lot of status reports and did a ton of cheer leading.

Many Pending Queries Complete

We tracked our progress on a white board and set and re-set achievable goals until all the work was complete. At the weekly sponsor call on Friday, everyone was singing our praises and stunned at the work we had done. My team assisted the site in resolving over 500 pending queries in around 3 days – a feat that nobody thought could be done so we surprised them all! I always was confident we would make the deadline because I had such a great team making the effort and the study staff was so motivated to meet the deadline. It was an eleventh hour delivery but we made it and we even beat some other sites to the finish line so that was satisfying, too!

Cleaning up the Source Documents

I sent the other monitors home early and then stayed Friday organizing the source, pulling stickies and monitoring notes, giving everything a final glance, and helping the SC draft file notes. I also reviewed all of the ICFs one final time and ensured all the source was signed with complete headers. Everyone at the site pitched in to help and we had it all cleaned up in no time. I got home around 9pm on Friday night and spent the weekend watching TV and lounging around the house. I even booked a little trip for this weekend and then a mini-break in mid-December with some of my banked PTO. Now I just have to tackle my monitoring reports – yikes! 😉

Feeling Great About Data Lock

I’m really happy with the site’s performance at the end and the state of the source and the database now that we have locked. I’ll return to my sites in January to perform the close-out visit and I’ll inquire with the project team whether there are other sites that need a COV or monitoring support so I can help there as well. In any case, I’m eager for a little home office time to put my personal and professional life back in order – both have been on hold for about three months – but I’m so glad I had the opportunity to work on this exciting project. I like to think that you never get more than you can handle, and that the challenges along the way make the achievement at the end so much more rich and enjoyable.

I’ll get back to posting here soon so please stay tuned and keep checking back. Thanks again for your continued interest!

About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at [email protected] anytime.

1 Comment

  • Anonymous

    March 16, 2010

    500 pending queries in approximately 3 days! Wow! You guys rock! I dream of being a CRA. Someone recently tried to talk me out of it due to the economy. I was already to move on to something “more practical” when I decided that I was going to continuing with pursuing a CRA position. (I worked in data management) Once I decided to continue, I found your blog. You have really given me new insight on this exciting (albeit challenging at times) field. Thank you Nadia!

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