Data Capture

Training Requirements

All staff that will be allocated the task of electronic case report form (eCRF) data entry prior to start of the study should be adequately trained and delegated this task on the delegation log. The sponsor will provide training on their chosen eCRF prior to allowing staff access.

To reduce the risk of data queries, ensure you are familiar with and have access to the eCRF guidelines to remind you of the following:

• Set passwords and usernames and do not share with others.

• When possible, avoid the use of abbreviations.

• The use of trade or generic names when inputting information about medication.

• The number of characters available for use in open fields and which eCRF pages are mandatory and which can be left blank. 

Keep to agreed timelines for entries and answering of queries. Each sponsor and study will have a different target but this usually lays between 3-7 days for data entry and query resolution. 

Tips for eCRF Data Entry 

• If possible, avoid completing your eCRF at peak data entry hours as this will slow the process (consider time zones).

• Ensure you have a stable and strong internet connection.

• Accurately enter visit information into the eCRF as soon as possible and as per protocol guidance.

• All entries should be supported by source data, for example in electronic health records. Direct entries into the eCRF are allowed but only if that has been specifically approved and stated in the protocol.

• Before logging out of the system check for accuracy of data entered and raised queries.

• When inputting into open fields be concise and work in chronological order of events.

• It may be useful to prevent queries by requesting a 1:1 session with the monitor to discuss data questions for easier resolution or clarification.

• CROs and sponsors often use the number of queries raised and how quickly they are resolved as a measure of data quality, so it is important to try to ensure accuracy first time.

Tips for Managing Data Queries 

• Double check the source document before you review and answer a query.

• Site staff must not answer queries that are the Investigator’s responsibility. Schedule a meeting to discuss the query and ensure that it is documented in the source.

• Make sure the original entry makes sense before confirming ‘original entry correct’.

• When answering a query, remember to also update the eCRF data.

• For a clear audit trail, give a clear explanation under ‘other' instead of choosing from the drop-down list of response options.

• If a query does not make sense to you, speak with the monitor for clarification.

• If there are recurrent illogical queries, report it to the monitor sooner rather than later.

• If you are not able to update data in the eCRF after answering a query, the page may be locked by the monitor or data management while working on it, try again later.

• Some eCRF systems have a more complicated query answering process before it shows as ‘resolved’, so make sure that you clearly understand the system you are working in and confirm by checking the eCRF completion guidance.