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Study units can occur either in parallel or sequentially. An example of = the parallel occurrence of study units is when administrative data collecti= on occurs at the same time as questionnaire data collection. These study un= it paths might be split following an initial study unit and later joined be= fore another study unit proceeds. During the join, an integration data processing p= ipeline might be inserted.
Study units are included in a protocol specification using the StudyUnit= Control. A StudyUnitControl references a study unit. A StudyUnitControl tak= es inputs and outputs. Inputs to a study unit might come from the study's a= rchive. Outputs from study units might be deposited in the archive.
Additionally, protocol specification includes the specification of the a= rrangement of instruments within a study unit. For example in a longitudina= l study at a visit several instruments might be administered. They might ad= ministered in a sequence with conditions, in any order or in some combinati= on of sequence and any order. The protocol specification orchestrates the o= rder of instruments within a study unit.
Instruments are included in a protocol specification using InstrumentCon= trol. InstrumentControl references an instrument. An InstrumentControl take= s inputs and outputs. Inputs to an instrument can include "preloads&qu= ot;. Outputs from an instrument can include "critical data items"= that figure into subsequent control constructs that play a role in the flo= w of instruments.