A Coordinator's Quick Guide to Avoiding Queries

Query resolution is a pain. How much time and energy is spent on the sponsor as well as the site's side taking care of queries throughout the study? I couldn't even take a guess, but I would wager it is a significant account. Certain types of queries will always happen, but a coordinator can and should be more proactive to limit the number of avoidable queries.

For the coordinator:

Take a detailed medical history, and remember the following:

- Each surgical procedure MUST have a corresponding diagnosis/reason. For example, do not leave a cholecystectomy without a corresponding indication for the surgery. It may seem insignificant, but as it stands right now data management could easily query the unattached surgical procedure.

- Make sure that medical history entries supersede or match medication start dates. It would not make much sense for a medication for high cholesterol to be reported as starting 5 years before the reported start date of the high cholesterol (unless of course the medication was given prophylactically, but that is a somewhat rare occurrence)

- For female subjects: their child bearing potential status should be documented in the medical history. This includes hysterectomies, a start date for menopause, bilateral tubal ligation, etc.

- Adverse events should list a diagnosis, not symptoms. Try to make life easier on yourself by grouping symptoms into one diagnosis, if possible. The classic example is grouping cough, sinus congestion, and sore throat as an upper respiratory infection.

- Don't be passive. If you have a question about a particular data entry field, ask your monitor. If you disagree with a query, let data management know. This takes time, and it may be fruitless, but it just may save you the time and effort of redoing many data points because of a misunderstanding of the completion guidelines.

-Read the CRF completion guidelines. They are written and sent to the sites for a reason. That reason is not take up space in the regulatory binder, so have a gander at them...you just might learn something!