October 2003
The Changing Roles of the Data Manager:
The Effect of Remote Data Capture
Data Management is seeing ever increasing usage of Electronic Data Capture (EDC) methods to process Clinical Trials. Many different systems are being used, from fax technologies through to Internet tools, and each of these is used for different things, from general communication and query resolution, to entry techniques and progress monitoring. One thing is certain from use of all these options; the role of the Data Manager is changing.
The following aims to provide an insight into how the role of the Data Manager, as well as the Investigational site and Clinical Monitor, is evolving following the use of the most intense method of electronic data capture, full Remote Data Capture (RDC), including remote entry and query resolution via the Internet.
We will consider the situation where the Data Manager completes all Data Management tasks for a study. In the current climate this is unlikely, but it allows us to judge the impact of RDC on Data Management as a whole, without the impact of altered company processes. We will also use the term Investigator to encompass not only the physician in charge at a study site, but also any site staff that maybe involved in entry, cleaning or authorisation of the study data.
Traditional Paper versus RDC
In the traditional paper process it would be considered essential to have a final protocol available before the first patient was recruited into the study. It would also be highly desirable to have CRFs designed, printed and distributed (at least to the early recruiting sites) before the first patient visit. However, some of the internal Data Management driven tasks are not so crucial to the first patient visit date, and may be more influenced by when the first CRFs are expected in house, or when processing is designated to start. The study database and checks need only be in place before any data can be entered. Any deadline before this may be desirable, but is not crucial to the success of the study. Similarly study conventions for data entry and data processing should be in place before either of these two tasks begin, this is likely to be a number of days after the first patient has completed their first visit.
The set-up of an RDC study has different priorities however. As before, the protocol should be finalised and CRFs/eCRFs designed before the first patient's visit (Of course with RDC the eCRF design process may differ from traditional paper forms. The process still needs to be completed, but may differ between an entirely electronic design, review and approval process and involvement of some established aspects of paper design.). However with RDC studies the database and eCRFs are being used in place of the paper CRFs. This means there is a requirement to have the database, eCRF screens and checks set up before first patient first visit. Whereas in paper studies you can prioritise the distribution of CRFs to those sites recruiting first and hence spread the workload, RDC studies all rely on the one database which must be completed prior to entry of the first data either during or immediately after the first visit. Also, your study conventions for entry and processing must be available for this time, to ensure the site is fully versed in the workings of the study, and to make certain the data will be consistently entered across all patients and sites.
During a study, the traditional processes rely on Data Management staff entering the data, then reviewing data, resolving discrepancies and sending any remaining queries to the Monitor and Investigator. The Monitor and Investigator then resolve the queries and send them back to the Data Manager. This is a step-by-step process that is repeated again and again until the data is as clean as required. In the RDC process these steps are more flexible, and focused on the Investigator, not the Data Manager. eCRFs directly replace paper CRFs, and queries are resolved upon entry of the data. Investigators, Monitors and Data Managers all liaise to resolve queries on an ongoing basis, without the strict, rigid approach required by pieces of paper shuffling round different people.
Finally, all studies, whether traditional paper, or ground-breaking remote data capture generally wrap up with reviews of data listings, tables and figures. This provides a view of the data as the authorities or other customers will see it. In RDC studies this is an ideal opportunity to focus on the consistency of the data that may have been generated, entered and cleaned by various different sites.
The Data Management role
Large studies have previously required huge effort from Data Management in terms of data entry, discrepancy review and query resolution. This has necessitated large teams of personnel, usually led by one lead, or project data manager, all working on a number of projects at any one time as the studies demand. Patient data is examined in great detail, on an individual, page-by-page basis, and a relatively long time is spent on each patient ensuring it is as clean as expected. This has required the majority of data management staff to be involved in a 'heads down' role, and resulted in a large amount of time spent on paper management tasks; filing, faxing, tracking, couriering etc. This conventional approach is rigid and unyielding, and focuses on a remote, insular process instead of open, direct communication. RDC methods turn this established approach upside down. The data manager no longer gets involved with the nitty-gritty, individual fragments of patient data. There is no longer any need to spend significant portions of time filing paper CRFs or queries, faxing or couriering items to and from the Monitor and Investigator, manually tracking individual items that come in or go out of the department. The inflexibility of paper processes is no longer an issue, flexibility and easy communication is now the main focus of the project. The lead Data Manager becomes the project expert, with fewer internal data management personnel under their direction, but with a far greater responsibility to the Investigators and Monitors. The number of these project Data Managers increases, as more time is spent coordinating activities throughout study set-up, and the course of the study. The Investigator and Monitor turn to them for reports on patient progress, help with difficult queries, and for assistance with training and technical issues. The Data Manager is there to encourage and assist the Investigator, to ensure timelines are met, and progress continues as expected throughout the course of the study. The project Data Manager has to do all the things they have always done, and more!
The Investigator role
The Investigator has always been required to enter all relevant study data on to study forms. The RDC process doesn't alleviate this requirement; the only difference is that the data is now collected on an electronic form rather than a paper one. The Investigator still needs to devote time to completing these forms, but it should require no extra time, nor less time, compared to paper (assuming proper training has been completed and verified). The biggest initial change is likely to be in the resolution of queries. Investigators will be confronted with queries as they enter the data, preliminary reactions may be that there are a lot of queries to resolve, but many errors that a Data Manager traditionally sees could be so easily resolved if the Investigator noticed them up front; incorrect years, missing data, inconsistent responses. These mistakes would take a matter of seconds for the Investigator to resolve up front, and with the effort required to process one query using conventional methods, provides a far more efficient method of query resolution. Use of Investigator entry into an RDC system will also eliminate the need for some queries altogether - no more illegible data to decipher for example. Investigators will also benefit from the lack of delay in receiving queries on the data. No longer is it a matter of weeks between patient visits and queries arriving, no longer does the Investigator need to search back through records to find the necessary responses. With queries being available almost 'real-time' the answers will be readily available. Finally, with a little time the Investigators will learn what is required of the data, and fewer errors will be made resulting overall in fewer queries to resolve. The onus is now in their hands.
The one item that may make the biggest impact on the Investigator is the requirement for approving the data. Paper processes require signatures and initials to authorise the completed CRFs and any changes made to these. The same requirement is needed for eCRFs, but now the obligation can be strictly enforced, therefore where the odd item may have slipped through the net previously, now that cannot be an option. The Investigator must make a specific effort toward the end of the study to check the data on the eCRF to ensure all the appropriate approvals are in place.
The Monitor's role
With the use of RDC, the Data Manager has the ability to accurately track patient progress as well as the ability to efficiently communicate direct with the Investigator. This results in the Monitor's responsibilities in this area diminishing, allowing more time for other local study activities; verification of data; recruitment, Investigator and patient compliance etc. The number of site visits is also likely to decrease as more information can be communicated and resolved on-line, resulting in the management of more sites (perhaps further away), or more studies per person.
Data Management role changes in RDC:
The view of data adjusts from in-depth, by patient, to global overviews of trends and inconsistencies
Automated tracking allows more focus on pro-active monitoring of site performance
Technical knowledge transforms the Data Manager into the focus of issues direct from the site
Shift in focus from heads down processing, to general project management, concentrated at study set up and closeout
Communication direct with the sites increases profile and importance of role
Site role changes in RDC:
The hand written CRF is replaced by an electronic version, resulting in less storage space required at site
The impetus of discrepancy resolution changes focus, now being driven by the site
Liaison with monitor becomes more focused on specific issues, as Data Manager takes the role of monitoring patient and query progress
Monitor role changes in RDC:
Time released from progress monitoring and query resolution allows focus on local site activities
Shift in communication techniques allow more off-site work
Less heads down monitoring work, more overall project work
In the Future
A lower number of Data Managers will manage more studies. More Data Managers will be in Lead or Project Data Management roles. The main focus of the Data Managers' responsibilities will be on managing study set-up and close out activities, monitoring study progress and troubleshooting issues. These tasks will become more Investigator orientated, resulting in the opportunity to further increase the responsibilities the Data Manager has to the Investigators on a global basis. Data Managers will begin to move away from established processing methods, and take on more aspects of the Monitors and Study Manager roles. Sites will develop into focused centres, using more site co-ordinators to process data from more projects. Monitors will become local experts rather than focusing on liaison and communication. Fewer people, at less expense, will process more studies.
I mentioned at the beginning that the role of the Data Manager is changing. I think the discussions above have proved that not only is this true, but it is also true for Monitors and Investigators throughout this technology driven industry.
Jo Marshall
Pfizer, Global Research & Development