Protocol Management

A collection protocol (CP) contains a set of guidelines that delineate what, how, and when the bio-specimens are to be collected; hence, a CP has the bio-specimen collection schedule for all registered participants. The creation of a CP provides the ability to define consent questions, time points and specimen collected per time point, in addition to defining derivatives and aliquots that need to be created on the collected bio-specimens. The OpenSpecimen system uses this information to create anticipated specimens for each participant registration and builds a study calendar based on the anticipated specimens. Operationally, this information can be used to predict workload per future time period and generate missing specimen reports by querying for specimens that are past the anticipated collection date. Moreover, there is support for complex protocols such as studies with arms, cycles, and phases.

Data captured in OpenSpecimen are categorized in three ways:

  1. clinical data
  2. pathology data and reports
  3. quality assurance and availability data.

Clinical data are represented as participants (i.e. patients), collection protocols, and participant protocol registration (PPI). Participants are persons enrolled in a study and the information obtained about those patients. Collection protocols are structured methodologies for when and how bio-specimens are collected from study participants and processed. Within the concept of participant protocol registration (PPI), the participant is registered through the study enrollment. Hence, the person is entered into the system and assigned a unique study number called the participant protocol identification (PPI) number, uniquely identifying that person and their bio-specimens; this PPI is then associated with a specific study or clinical trial.

The other concept is that of the specimen collection group (SCG), or the point in time that a specimen (or group of specimens) is collected. For some clinical trials, participants may have specimens collected at different time points. For example, there may be a pre-therapy time point where a tissue biopsy is collected and a time at surgical resection where a piece of tissue is also collected. At each of these time points, there may be tissue and blood collected, which is referred to as a specimen collection group. Within the SCG are the specimens themselves (e.g. paraffin blocks, serum, plasma, frozen tissue, etc.) in which other specimens can be derived (e.g. whole blood to plasma) or aliquoted (e.g. four vials of plasma).