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Rules and derivations
Rules of type Clintrial Rule or Clintrial Derivation run only in the Clintrial database once the protocol is recreated there. Similarly, rules of type Form Rule, Conversion, or Calculation run only in the InForm database.
If a rule exists in the Clintrial database, and you want to run an equivalent rule in the InForm database, you must use the Central Designer software to create an InForm rule that uses the same logic as the Clintrial rule.
Clintrial rules and derivations can include calls to functions and procedures in PL/SQL packages that are provided with the software or created by the user. These functions include:
- Basic functions—To investigate the structure of the database.
- String functions—To manipulate string data.
- User-defined functions—To use either in a specific protocol or for an entire instance. Instance-wide functions would be available to all protocols.
In a similar manner, InForm rules can call object methods provided with the Central Designer software that perform various functions. For more information, see the Central Designer guide Working with Rules and Logical Schema.
When replicating the behavior of a rule from one scripting language to the other, you must ensure that all functionality contained in outside functions or object calls is re-created in the new language.
Rules that run in the InForm database trigger real-time query messages for EDC data that are immediately visible to the InForm user. However, rules that are triggered by EDC data in the Clintrial database return delayed query messages to the InForm user according to the synchronization schedule. Therefore, it is recommended that as many rules as possible be implemented in the InForm database with Central Designer, rather than in the Clintrial database. For more information, see Using rules in an integrated study.
For hybrid studies, if you want the same validation performed on EDC and paper-based data entry, duplicate sets of rules must exist in both databases unless you perform all validation by using Clintrial rules. If you design a hybrid study with duplicate sets of rules, each must have the proper rule type and use the correct script language. You can prevent an EDC data entry action from generating two queries through the use of the DB_ID parameter value. You can modify the Clintrial software to ignore EDC data - that is data with a DB_ID value of 9999. For more information, see Managing rules and queries in a hybrid study.
