Research Objective
- High quality data management with respect of rules of regulation (GCP, ethics, privacy).
- Work axis #1 will develop and implement data management SOPs across PICRN participating sites.
- Rapid access to PICRN information that is generated by different Themes and stored in different databases, hosted by different systems. Main issue is lack of standardization regarding variables’ definition and coding.
- Work axis #2 will identify/define a “common terminology” for PICRN data management using existing forms, variables, standard terms, coding frames and standard dictionaries.
- Work axis #3 will define “minimum information for vaccine studies”. This activity will incorporate the common terminology (above) and identify gaps. Definitions for missing elements will be worked upon by the PCIRN network members.
- Work axis #4 will identify ontology terms relevant to the PCIRN minimum information. Missing terms will be added in collaboration with international ontology groups, and unique resource identifiers will be provided to the PCIRN members.
- Rapid use of PICRN information generated by different Themes and stored in different databases, hosted by different systems.
- Work axis #5 will focus on extracting relevant information from each data base and centralizing the summary information. Instead of transferring all databases in a central place (difficult for many reasons), this axis of activity will focus on organizing at each site a “data extraction and analysis process” to generate a “local summary output” of relevant information. All summary outputs will be centralized and incorporated into an overall summary output, representing PICRN activity.
- Automated linkage of clinical and biological data for rapid interpretation of study results, hence rapid decision.
- Work axis #6 will focus on establishing/programming automated transfer of biological data to be integrated with clinical data for rapid analysis. This activity will be conducted with Rapid Trial.
