query management understanding discrepancies *discrepancies are inconsistencies found in the clinical trial data which need to be corrected as per the study protocol (the guiding document) *for better query management, one has to know the source or origin of discrepancies *data in clinical trial should be congruent with the study protocol data inconsistencies discrepancy types completeness & consistency: *checks for empty fields *looking for all related items *cross-checking values real-world checks: *range checks *discrete value checks *one value greater/less than/equal to another discrepancy types quality control: *are dates in logical sequence? *is header information consistent? *any missing visits or pages? compliance & safety: *are visits in compliance with protocol? *inclusion/exclusion criteria met? *checking lab values against normals *comparison of values over time sources of discrepancies *manual review of data and crfs by clinical team or data management *computerized checks of data by the clinical data management system: validation/discrepancy designing and build-up into the database common features included in discrepancy systems *source of the discrepancy *date & time it was identified *linked or duplicate discrepancies *status of discrepancy in the system *data and time query sent to investigator *query form identifier *final resolution *date & time of resolution *source of the resolution registering discrepancies

discrepancy management systems are designed to: *supplement the data management system audit trail *provide summary information on the causes of discrepancies *provide metrics on the time to resolve issues *help eliminate over-reporting and reporting of duplicates main tool for query management *clinical data management staff send out data clarification forms or dcfs in the process of query management *other names given to this form: * query forms * correction forms * discrepancy forms process of query management *create *send *track *resolve *re-query creating queries *discrepancies entered onto query form by hand based on reports from the discrepancy management system, or system may create them automatically *in the case of remote data entry systems, queries are entered directly into database *discrepancies covered on a single form will all belong to one site but may refer to: *one or more patient for that investigator *a single patient but multiple crf pages *a single patient and a single crf page only sending queries *query form delivered to site via fax, paper mail, the cra in person, or e-mail *in the case of remote data entry systems, the queries are immediately accessible to the investigator, who can view the query online tracking queries *data management tracks flow of queries to and fro between self and investigator *data management ensures that query responses are received and integrated within the specified timeliness *tracking spreadsheets to be maintained tracking queries resolving queries *data management integrates the query response into the database *common types of resolutions: *the value in question maybe correct as is *an actual measurement may replace a missing value *a corrected value may replace an incorrect value *the value maybe wrong but no corrected value is available

re-queries *needed when the investigator provides *no response *incorrect response *inconsistent response *incomplete response (including signature) *same response re-queries *possible approaches to handle incomplete resolutions: *re-issue the discrepancy on a new query form if corrections take place on the form *leave that one discrepancy as unresolved and await a re-send of the query form *leave it as unresolved and await correct crf data management issues dcf discrepancy statuses *identified or registered *reviewed and still open *sent to investigator *duplicate or linked *data updated resolution types *resolved (with data update) *as is (i.e., not a problem) *cant be resolved (but wrong) *data management edit resolution sources *cra *data management *site, by phone *site, by query form general tips for query wording *good understanding of guidelines *knowledge about protocol *state a problem in a simple way *be precise or to the point while wording the query text *use proper punctuation and grammatically correct sentences *avoid repetition of words in query text formula for query writing

*the formula of l s a *locate the discrepancy *state the discrepancy *ask for resolution *a simple way of going about any query text is to first mention the location of the query, then state the discrepancy/issue, and later ask for the resolution *note: a query text should never be leading to the investigator illogical data *date of birth given as 30 feb 1977 *this is an example of illogical data *since it is very clear that the february month has no 30 th day, this data has to be cross verified with the investigator query for illogical data: 30 feb 1977 query text: *on page 2, demography record, the date of birth is recorded as 30 feb 1977. please verify the date of birth. as per the formula for query writing, *on page 2, demography record (location of the discrepancy) *the date of birth is recorded as 30 feb 1977 (discrepancy stated) *please provide the correct date (resolution requested) inconsistent data *situation: the start date of paracetamol at visit 2 is given as 23-feb-1984 and is continuing. at the next visit i.e., at visit 3, the start date is given as 25feb-1984. *understanding the problem: paracetamol at visit 2 was given and was not stopped at visit 2. hence, it should have the same start date at next visit as we ll. *ambiguity: it is also possible that the subject might have stopped taking paracetamol at visit 2 and taken a different course of paracetamol at next visitvisit 3 and hence a different start date 25-feb-1984 was recorded. paracetamol with different start dates at subsequent visits query text: *on page 20 visit 2, medication paracetamol (start date 23-feb-1984) and continuing is recorded. however, in the subsequent visit 3, medication is recor ded with a different start date 25-feb-1984. please verify the correct start dates for the medication at both the visits, else provide a stop date for the medication at visit 2. incomplete/missing data

*on demography page, sex and ethnicity of the subject is not mentioned query text: *on page 2, demography record, sex and ethnicity of the subject is not recorded. please provide the required data. data without units *weight of the subject is recorded without units query text: *on page 5, weight of the subject is recorded as 150, however the unit of weight is not recorded. please provide weight recorded with the applicable units. qa/qc *all changes to database via query forms to be documented and captured in audit trail *differences between database and crf to be supported by query response *accurate query integration key component of audit findings *consistent inaccuracies in query response communicated to investigator in the form of feedback