Patient Enrollment/Recruitment Tracking

The Recruitment Tracking feature is needed to track the recruitment of a study against a goal number of subjects. The system will track pre-screens, screened subjects and enrollment subjects and control the process of moving a subject through the process. The goal level is a preset variable.

Each clinical site will keep track of each potential study subject in pre-screening by entering some very basic information including an automatically assigned sequential number (count), a letter code and estimated consent date. C-TASC systems can NOT accept any specific identifiers. Once entered the potential subject will appear on the Recruitment Tracking list for the site. Each potential subject will have the already mentioned number, letter code and consent date along with a status, an available “Screened Date” and “Consent Received Date” and a grayed out “Enroll” link. When the site staff completes a screening for a potential subject, they enter the date of that screening in the “Screen Date” field next to appropriate letter code and select “qualified” or “unqualified”. If they then decide to enroll the subject, they will collect a consent offline and then enter the “consent date” into the system. Once the consent date is entered the “Enroll” link will be enabled. Site staff can then enter an enrollment form on this subject by clicking that link and completing the Enrollment form that will then pop-up. At each step status will change from –pre-screen to screened – qualified or screened unqualified, to consented, to enrolled. If, at any point the potential subject drops out of the process the status will change to “dropped out”.

Visit Tracking/Scheduling

A critical part of all clinical studies is scheduling, tracking and rescheduling subject visits. This module of the overall Clinical Trial Protocol Management (CTPM) system will enable clients to create visit intervals to provide a range of dates in which a subject visit should be scheduled. It will also interface with the Forms tool to provide an Expected Visit Task List and manage actual visit scheduling on site.

Most clinical studies require a subject to visit clinics or other sites multiple times. Often, a study protocol requires visits to occur according to a certain schedule. Schedules are typically based on a protocol-defined interval. These intervals can change based on observations of a subject at a visit, due to changes in study goals or as part of a natural progression designed into the study.

When a study is originally configured, the protocol will typically define how often each group of subjects needs to visit the clinic or other location (typically for a test or procedure the clinic can not conduct on its own). Each subject group can have a different interval. Each time a subject visits the clinic, staff attempt to schedule a specific time and date for the next visit with the subject. It is not uncommon for the subject to call in and reschedule or to miss a visit and require a quick reschedule.

Subjects may also change from one interval to another or require an unscheduled visit due to changes in subject circumstances. For example a subject may be admitted to a health care institution for an issue that may or may not be study related after which a study visit is required to determine the impact on study participation.

Within CTPM, we will provide a tool that configures one or more visit intervals per study and allows clinics to put each subject into any one interval setup for that study. Prior to a subject visit, clinic staff will be able to pull up a list of expected work to be completed at upcoming visits. Clinic staff, at any subject visit, will be provided a targeted next visit date as well as a no sooner than and no later than date representing the expected range of the interval. They will then be able to set a date and time with the subject and store that in the system. The system will then provide a report of daily, weekly or monthly upcoming visits.