Data can be prepared for submission to CTMS in three ways. The traditional method is by filling out the paper standard NCI/DCTC/CTEP CTMS Case Report Forms and sending them to CTMS for key-entry. Many sites prefer the convenience of an electronic local data capture system, and for this purpose CTMS provides free copies of ACES®. Since ACES® is a mini-database system, it additionally provides local reporting capabilities. (ACES® can also be used for non-CTMS studies, and to consolidate data from multi-site studies.) Information captured in ACES® is periodically extracted and transmitted to CTMS through use of a secure, encrypted email utility. For institutions which have their own clinical data systems, CTMS will accept the upload of data files extracted from that system which follow the CTMS approved formatting specification. CTMS monitors trials in progress, rather than retrospectively, so that CTEP can take immediate and prospective action if problems are discovered. For this to be effective, data submissions must be made in a "timely" manner. This is because lapses in submission could mean that patterns of toxicity or deviations from the protocol which might affect patient safety or study analysis could go unobserved and thus uncorrected. CTEP construes Good Clinical Practice in data management to include the timely and complete submission of data to CTMS.

To meet its goals without unduly burdening the study sites, CTMS has adopted a policy of expecting data to be submitted within two weeks of its becoming available to the site data management team. This policy ensures that data will be monitored while it is fresh, and that reports generated for CTEP will not be based on stale data. Most sites fulfill this by instituting a regular bi-weekly submission: sites using paper CRFs accumulate them as they are generated and send them in batches; sites using electronic transfers from in-house systems arrange to extract data on this schedule. CTMS has no objection to more frequent submissions; weekly is fine too. Note that the policy contains an important qualifier which is sometimes overlooked; that the "clock" starts when the data becomes available. Thus an Enrollment CRF should be filled in immediately when a patient is registered, while lab tests are not expected until the results are actually obtained back from the lab. Drug Administration and Adverse Event CRFs are expected shortly after the events occur, but Pharmacokinetics might not be available until samples have been processed in a batch. Holding all data until a full course of treatment has been completed is definitely not acceptable, since CTMS expects to monitor the "study in progress".

The CTMS data management group is flexible in recognizing the realities of site data management (illness, computer failure, etc.), but is obliged to keep CTEP apprised when patterns of delinquent data submission are observed. CTMS will issue a warning in such cases, and work with the site to bring the data flow into compliance. Unjustified failure will lead to administrative action by CTEP. The experience of CTMS has been that institutions with effective data management systems and support have had no problem or objection in meeting the "two-week" policy.