Regulatory Concerns Related to Data Management
Data management and analysis is an important component of Triad projects.
Data management and analysis is an important component of Triad projects. Some of the issues associated with data management are particularly relevant to regulators. They include:
- Timely dissemination of real-time data
- Balancing the needs for data review with the need for rapid data turn-around
- Data archiving requirements
- Beyond the project: broader uses of data sets
Timely Dissemination of Real-time Data
Because regulatory participation is encouraged and expected as part of the in-field, real-time decision-making process, regulators must be assured that they are receiving up-to-date results and analysis in time for them to have an influence on the decision-making process. This type of participation is essential despite the budget and staff limitations common in many regulatory agencies that do not allow a full-time field presence of regulatory personnel.
Project managers must recognize that a number of key participants in project decision-making may be remote from the site during significant periods of time. The data management plan for the project should recognize this as an important issue and make provisions for the rapid turn-around and distribution of results and data analyses. Internet-based dissemination of this information is an indispensable way to meet this objective. At a minimum, e-mail should be used to distribute data and results quickly in standardized formats using software that can be expected to be resident on most users' computers.
Depending on the scale of the project, Web sites can be a very useful means for making information available quickly. In addition, other important project reference and scheduling information can be maintained on project Web sites.
Balancing Needs for Data Review with the Need for Rapid Data Turn-Around
The level of data review required for making real-time decisions is often a consideration on Triad projects. The key to this issue resides in the QAPP. The goal of a Triad project is to gather data of sufficient quality to make the decisions required by the project. For decisions related to risk, it is often the case that the final judgment about the adequacy of the data to be used in the risk assessment is not complete until the data are fully reviewed. On the other hand, project risk related to defining the extent of the contamination during the investigation phase usually falls heavily on the project manager. In this case, the review process may be considerably more limited because the goals of delineating the extent of contamination and optimizing the productivity of the field team requires a quick turn-around on results and can tolerate a higher rate of error in the results.
The key is to link data review needs to the decision that is being addressed and the measurement technique being used, and then document the degree to which data review must take place for the various combinations of data types and decisions contained in the QAPP. Further, it is very important that the provisions of the QAPP be carefully followed during the investigation.
Specific regulatory requirements may also call for certain levels of data review. Since the Triad approach recognizes that regulations must be followed, there should be no conflict in this area. However, over time, the use of the Triad approach with its emphasis on reducing overall decision uncertainty may cause some regulations to be reconsidered because of the need to better balance analytical error against other sources of decision error.
Data Archiving Requirements
Another important issue related to data management on Triad projects is deciding what records must be preserved for the long-term documentation of the decision-making process. Typically, regulations specify the type and detail of data and documents to be preserved for the record (e.g., CERCLA administrative record requirements). Because Triad does not change the documentation process specified by the various environmental regulations, the existing framework for documenting and archiving project records is expected to be adequate. However, as part of the systematic planning process, it is important for project managers and regulators to be aware of what records must be included in the project archives and make sure the mechanisms are in place to capture the appropriate documentation.
Beyond the Project: Broader Uses of Data Sets
Many regulatory agencies recognize the value of collecting important environmental data beyond the scope of immediate projects. For instance, high quality data sets are collected on background concentrations of metals and other soil, water, and sediment constituents. Or, project data may contribute to better understanding the regional groundwater regime.
Because of the high value of these data to other-than-project needs, projects may be requested to collect additional information and/or report data in formats that otherwise would not occur on the project. Caution should be taken when trying to develop global requirements for the type and quality of data collected by projects. Such global specifications may conflict with project-specific data objectives, add to project costs, and delaying sampling and reporting schedules. If data objectives that span beyond the current project are imposed on the project, then it is important to include them early in the systematic planning process so that negative impacts of such demands can be minimized and managed.