Glossary

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Audit Log Is a file that capture every single transaction that runs on the OpenClinica database (21 CFR Part 11 compliance).

CRF CRF is the abbreviation for Case Report Form. It is a special form to collect study related information of a study subject.

Null Values When creating an Event Definition, the user can choose to apply certain sets of letters to represent null values. Any null values selected will be considered reserved words for that specific CRF. A user entering data can not use those codes as string literals; eg - if \'NA\' is a selected null, a user cannot input \'Na\' to indicate sodium. For a complete list click here.

Job In OpenClinica we decide between Export Data Job and Import Data Job. As admin you can create different jobs which will be run automatically and in your choosen frequncy.

Person ID The person ID is a field that can be required or optional, depending on the way the study is set up. This is the unique identifier for a subject that can be used across all studies. It is a way of keeping track and reporting on where one person is within mutliple studies.

Site Location where the study is taking place.

Study Event A visit of a study subject at a site during the study is called a Study Event. Each Study Event can contain one or more CRFs. Before you can assign a Study Event to a study subject you need to define it (see Study Event Definition).

Study Event Definition A Study Event Definition describes a type of study event that takes place during a study.

Subject Group Class Is a class of group categories that are related and mutually exclusive. For instance, when creating a group class you may create a Group Class called 'Trial Arm' with the groups 'Treatment A', 'Treatment B', and 'Placebo'. You may then assign the subject to one of these groups. If you specify the Subject Assignment as 'Required', you must assign the subject to one of these groups upon creating the subject record. You can have multiple Group Classes within a study.

User Person using the software.


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code name definition
NI No Information No information whatsoever can be inferred from this exceptional value. This is the most general exceptional value. It is also the default exceptional value.
NA not applicable No proper value is applicable in this context (e.g., last menstrual period for a male).
UNK unknown A proper value is applicable, but not known.
NASK not asked This information has not been sought (e.g., patient was not asked)
ASKU asked but unknown Information was sought but not found (e.g., patient was asked but didn't know)
NAV temporarily unavailable Information is not available at this time but it is expected that it will be available later.
OTH other The actual value is not an element in the value domain of a variable. (e.g., concept not provided by required code system).
PINF positive infinity Positive infinity of numbers.
NINF negative infinity Negative infinity of numbers.
MSK masked There is information on this item available but it has not been provided by the sender due to security, privacy or other reasons. There may be an alternate mechanism for gaining access to this information. Note: using this null flavor does provide information that may be a breach of confidentiality. Its primary purpose is for those circumstances where it is necessary to inform the receiver that the information does exist.
NP not present Value is not present in a message. This is only defined in messages, never in application data! All values not present in the message must be replaced by the applicable default, or no-information (NI) as the default of all defaults.

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