Online Data Entry Jobs
Computer-assisted data entry, that is, electronic data capture at the physician's workplace (hospital or office) and at the time of the patient's visit or procedure, offers at least four advantages over paper forms Data entry can be via keyboard, touch-screen, voice-recognition, or a hand-held device. Of course, the mandatory paper form required by many regulatory agencies is easily printed for signature afterward.3 Computer-assisted data entry means there are no intermediate forms nothing is scrawled on the backs of envelopes or left to memory nor are there errors in transcription, in copying and recopying. Computer-assisted data entry facilitates monitoring and allows you to stay on top of problems. Once the data are in the computer, they can be collated back at your facility with data from other patients and examined for trends. If you detect ambiguities in questions or an overused other category during the tryout phase, the electronic form is easily modified. You can also...
Computer-assisted data entry offers at least six advantages over paper case report forms Ease of access. Generally, the same software that simplifies data entry makes it easy for the noncomputer professional to access and display the result. (We expand on this point in the next chapter.) Both your staff and the regulatory agency will have earlier access to trial data compared with paper CRFs. 1. Developing and testing the data entry software
Responsibility for choosing the appropriate software for data entry, data management, and statistical analysis is normally divided among the lead software engineer, the data manager, and the statistician. (Subject, of course, to corporate approval, a topic on which we wax apoplectic in Chapter 10.) The project leader may need to step in to resolve conflicts. The lead software developer need not be a member of the programming team, but she must possess a general knowledge of both data entry and data management software and be able to prepare and maintain a flow or Gant chart for the development process. She bears overall responsibility for assembling the field specifications in collaboration with the clinical research monitor, and for approving the final screen designs. Ideally, she will also possess a knowledge of the statistical analysis software that will be employed later on. A team of programmers will be needed to develop the data entry screens. They will not be working alone but...
Computer-assisted data entry offers a tremendous opportunity for early detection of deleterious trends resulting from discrepancies in trial design or investigator inaction. It does, that is, if we pay attention to and act on the information we receive. A typical set of clinical trials today costs what that wasted spaceshot did in the 1950s. We needn't make the same mistakes that were made back then. Find the discrepancies and take advantage of the immediate availability of information that computer-assisted data entry provides to plug the holes as they arise.
Development of programs for data analysis should be started on or before the actual beginning of the trials. One or more statistical programmers will work under the direction of the statistician. The ideal statistical programmer will also be a member of the team that develops the data entry screens. (Candidly, programmers who possess the dual set of skills are in extremely short supply.) 1 Develop data entry screens 2+ LP Develop data entry screens
Enrollment must be monitored on a continuous basis to forestall the tendency of the very few less than ethical physicians to enroll unsuitable subjects or to skip (or, more often, sidestep) informed consent. Ideally eligibility forms should be reviewed on the day they are completed and prior to the start of the trial itself. (The notable exception being when immediate intervention is dictated.) Fortunately, computer-assisted data entry facilitates rapid review. But computerized analysis alone is not adequate. Frequent visits should be made routinely to each investigator's site.
Besides the already mentioned (1) lockstep program and the introduction of both (2) collection units and the split record function, Table 3 summarizes helpful tools for efficient databasing of entomological collections. (3) The visualisation of geo-referenced locations (named areas or sites) during data entry allows an immediate identification of outliers if, for example, longitude data are erroneously related to the East instead of the West (Fig.3). 3. Visualisation of geo-referenced places sites during data entry
Properly utilized, technology can greatly facilitate surgical management. A potential example is the bar coding now seen in every facet of our daily lives. At a patient's first office visit, he or she can be given a bar code, which is entered into a computer. On the morning of surgery, the computer can give the patient a wake up call at 5 30 A.M. Upon arrival at the surgical center, the patient can be logged in by bar code. Each step in the process can be tracked how many minutes it took for the patient to get to the OR, how long it took for the anesthesiologist and the resident to interview the patient in the preoperative holding area, and how long it took to position the patient. Essentially, this process is a variation on patient tracking and data acquisition that minimizes variability with respect to data entry. Tracking information can also be displayed on a video monitor, so that the patient's location and current status within the surgical care process are available on an...
Final data entry of existing specimens into the database_ (2) The next step is to check the validity of the systematic information against a current catalogue. (3) Next, the updated systematic information including synonyms, hierarchy of taxa, authors, year, etc. can be entered into the database establishing a taxonomic catalogue. At this point the various specimen collections can be merged into one main collection. (4) While the material is at hand again simultaneously a secondary data capture can take place by listing locations (gathering sites), collectors, determinators, etc. (5) The list of locations can be completed in a similar manner to the taxonomic catalogue by adding geographical attributes such as latitude, longitude and in a hierarchy such as province area, state, country, continent ocean and the link to the zoogeographical region. (6) The resulting geographical catalogue can be entered into the database like the previous lists. (7) The final data entry can be made now...
Administrative data were not, however, collected for the purposes of research. Quality control of coding and data entry rarely achieve the levels achieved in data collection efforts done specifically for research. The completeness and accuracy of data elements in administrative databases are almost never as good as in planned research. The sheer volume of data collected routinely in health care settings makes assurance of the completeness and accuracy of each element difficult.
In addition to providing the benefits of flexible data entry (accepting close misspellings such as asperin ), domain tables provide faster queries, faster sorting, lower storage and ease in updating. They're a standard part of most relational systems, present in both the least and the most expensive. Further guidelines concerning keys, database structures, and data formats may be found in the documents CDISC Submission Metadata Model and Introduction to the CDISC Submissions Data Domain Models which can be downloaded from
As noted in previous chapters, the programs that can be used for interim analyses can also be used for analysis of the final results. Thus development of the programs used for analysis should begin at the same time as or just prior to completion of the programs used for data entry.
Report forms were the primary offenders. They pointed out that training and supervision of data managers, precision in writing protocols, standardization of the data entry process, and the use of a checklist for therapy data and treatment toxicities would have avoided many of these errors.
Your implementation team will consist of a pharmacologist and or manufacturing specialist who will be responsible for providing the drugs and or devices needed for the trials, clinical research monitors who will train, deliver, and monitor the ongoing process, technical writers to prepare the detailed procedures manuals for use by the investigators, the lead software developer who will be responsible for developing the data entry screens as described in Chapter 10, and the database manager who will be responsible for maintaining the integrity of the collected data as described in Chapter 11. The qualifications for the latter two individuals are outlined in the next section.
Each trial is assigned a Web site that becomes the central workplace for all trial personnel, and warehouse for all trial data and records. Data entry includes range and logic checks. ClinicalTrialsNet Inc., 12 John Street, Charleston, SC 29403, (877) 552-8638, info clinicaltrialsnet.com.
The purpose of stress testing a program before releasing it for use is to detect all problems in a setting where there is little or no risk of turning off potential users. Stress testing may follow a script or may be a totally ad hoc process. A noncomputer professional should perform the test, ideally someone with a background similar to those who will be doing the data entry at the investigators' sites. As the CRMs will be responsible for training in data entry, and must master use of the data entry screens, I recommend that the CRMs be used for the final stages of ad hoc testing so that they can combine the latter task with the former. The effort preceding computer-assisted data entry is time-consuming, but it is still only a fraction of the time that will be wasted if an inferior data entry process is allowed to slip by.
Location of Data Entry Software Which of the next two options to adopt will depend on the volume of data you expect to receive from each treatment center. With either alternative, a second data entry program reads the transmitted files and enters the records into the database. Human intervention is required only to start the program and slip the CD into the host computer's CD drive. Web-based data entry is gaining increasing support. The software is the easiest to update and maintain, and one can be assured that all sites are making use of the same version. On the down side, links to the web are often down and the Web (Internet) itself isn't always up. Separating the two stages of data entry guarantees that investigators' contact with the database is strictly limited. They can enter their data in the database, but they cannot modify it once it is entered. Nor can they access the database and be exposed to findings that might color their own observations. See Table 11.1 for a more...
In computer-aided data entry, the computer's screen, approximately 80 characters wide by 24 lines, plays the role that printed case report forms once did. There is no need to copy or ape the printed form. The focus should be on making effective use of the screen. For example, rather than trying to cram a single form onto a single screen, the layout should be dictated by the comfort and convenience of the potential user.
When selecting a database management system, there are five key areas on which to focus (1) ease of formulating queries, (2) speed of retrieval of data, (3) ease of updating data, (4) ease of restructuring the database, (5) ease of integrating other applications including data entry and statistical software.
The use of computer-assisted direct data entry has eliminated most discrepancies of the first type with the possible exceptions of the results of specialty laboratories, which are used so infrequently that supplying them with computers would not have been cost effective, and the findings of external committees, which are normally provided in letter form.
Now that you've seen things from the investigator's point of view, you know that a hotline needs to be part of the data entry process. Ever have the experience of being told to call back the next day because the person on the other end of the line could only answer simple questions When you set up your hotline, staff it with knowledgeable personnel.
The database, the level of access they should have, and the files they should be permitted to access. Just prior to the start of full-scale data entry, the database manager should submit a chart similar to Table 11.2. to you for your approval. Thereafter, all decisions as to access to the data will be yours alone.
A major advantage of computer-assisted direct data entry is that it facilitates monitoring the results to obtain early indications of the success or failure of the drug or device that is under test. (See Chapter 14.) Tumors regress, Alzheimer's patients become and stay coherent, and six recipients of your new analgesic get severe stomach cramps. You crack the treatment code and determine that the results favor one treatment over the other. Or, perhaps, that there is so little
An intricate coding system using a page name and an event would have worked had, for example, the one-month follow-up actually taken place exactly one month after the start of the intervention. But it never did except on rare occasions. Since the occasional form did not get entered in the database (and since Bumbling was using paper forms for initial data entry, there were always forms that did not get entered in the database), one could never be sure which form went with which date in the visit register.
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