Data collection forms

In a data collection system that was developed in the transportation sector, the application of these principles generated the following format for a data collection form ... 

Documentation of data origin is essential. Each completed data collection form needs to contain a file reference number or code to connect it to the documentation sources. This provides an essential trail to audit data quality, to confirm risk or reliability estimates or to investigate data values that appear questionable. Procedures to control data during handling, processing, recording, and reviewing are also necessary to prevent loss of data and to assure that opportunities are not lost to check the content of a form, by... 

Given the large variety of maintenance and operating systems and procedures that exist within the CPI, it is impossible to provide a set of data collection forms that will completely satisfy the requirements of all users. However, sample forms are included that contain many of the elements that data collection efforts must address. Using these as a reference, the reader should be able to capture necessary raw data. 

Electronic-based data collection and management systems rely heavily on computer hardware and software at both the participating sites and the coordinating centers. The hallmark of the electronic-based data collection and management systems is the elimination of paper data collection forms. Instead of recording data on paper forms, data collectors enter data directly into a computer system where an electronic data record is generated for each form. The method of data transfer to the central location depends on the type of the electronic-based data collection and management system. 

Computer applications allow for defining and managing several important nonclinical data types that are managed by the system itself. Such data are referred to as metadata or control data. These are information such as domain-specific descriptions, application conditions, parameters, and methods in a repository. Control data fields can be part of the data collection forms or in system-defined tables. Some of these control fields include electronic signatures, form status, transmission date, transmission number, field completed, and memo fields (large text format). The database contains tables for reference ranges, visit schedule, form schedule, labels, and drug codes. 

The explosion of graphical software and the ability of database management systems to store graphical data provide a mechanism for designing and implementing clip art to convey certain meaning to the user. For example traffic lights have been used to convey the status of data collection forms. 

Audits of each phase of the study should include personnel training, preparation of collection forms, application calibration, each sample collection procedure, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage. Data collection in the field is often tedious if automated logging devices are not in place. To ensure data integrity, the paper and ink used for field studies should be waterproof. Each data collection form should contain appropriate locations for information detailing the time and location of sample collection, sample transport and sample analysis. Data collection forms should be stored in an orderly fashion in a secure location immediately upon return of field teams from the field at the end of each day. It is also important for data quality for studies to collect necessary field data seven days per week when required. In our experience, poor study quality is likely when field sample and data collection do not proceed on weekends. 

Valid analysis cannot be conducted unless one can distinguish animals which were examined and did not have the relevant response and animals which were not examined. It can also be important clearly to identify why data are missing. Table 22.4 identifies some basic rules for effective design of data collection forms. 

Post-It notes— various sizes and colors data collection forms... 

A variety of data, either numerical or non-numerical can be gathered in a systematic maimer for a clear and objective picture of the facts. This is the data collection form. Such forms are very common in the analytical laboratories and are used to collect and record data and facilitate comparisons. 

Tools for Quality Improvement Data Collection Form... 

For computer workstations, the workstation configuration must be verified using the technical design specification. The result of the verification must be documented using the data collection forms located in the approved protocol. 

All installation qualification activities and resulting data must be verified by a second (independent) person. Evidence of verification activities may be confirmed by signing of the corresponding data collection form verification activities must include the date on which the activity was performed. The reviewer s signature indicates that the test was completed as expected, that the acceptance criteria were met, and that the appropriate documentation/ evidence (if applicable) was collected. 

Design your CRFs accordingly. Do not start by simply deciding to use the data collection forms that were used in previous studies. If there are some questions on previous forms that address the collection of data you need, can those questions be improved ... 

The CRF design process can begin either following or concurrent with the protocol development. Well-designed data collection forms are critical to achieve the objectives of the clinical trial. Consideration should be given to the content, format, and layout of the forms since all these factors contribute to the overall quality and accuracy of the data that will be collected, processed, and reported. 

Any document used to collect research data on clinical study subjects may be genetically classed as a data collection form. These completed forms provide evidence of the research conducted. The most common type of data collection form is the CRF. Other types of data collection forms include... 

All research personnel must search for clues about safety events from many sources, such as information in clinical records at the study sites information in data collection forms (e.g. CRFs, diary cards, quality-of-life forms, psychiatric rating scales, etc.), occurrence of missed and/or unscheduled visits, dropouts and withdrawals use of any concomitant medications/devices and abnormal laboratory data. AEs may also occur simply as a result of study procedures and study participation. Information about definitions of AEs and requirements for reporting AEs must be clearly stated in the protocol and explained to the site staff, who must also be educated in the correct procedure and immediate requirement for reporting any AE suspected to be serious or unexpected as per the regulatory definitions. 

The primary purpose of source documents is for the care of the study subject from a clinical perspective the primary purpose of CRFs is to collect research data. CRFs (and other data collection forms) generally cannot substitute as source documents. Data entered in CRFs should generally be supported by source data in source... 

The basic format of the history interview will apply to all settings, including acute care, long-term care, ambulatory care, and retail, and can be adjusted to the specific needs of that setting. Utilization of patient data collection forms may be useful for documentation purposes and for guiding the flow and consistency of the interview. There are many sources for the format of data collection forms, which are discussed in a later section. 

Many sources have good examples of patient data collection forms.An example of a patient history form is given in Fig. 1. The format of the form will require modification for the specific care setting and goals of the individual practitioner. 

UAAC> 2i To evaluate impact of clinical pharmacy interventions on cost and quality of patient care COD None Personnel costs Physician acceptance, DCA, various quality indicators Annual extrapolated cost savings 19,076 Documented cost and quality using daily patient data collection forms... 

The administrative cost of voucher schemes is one of their main drawbacks. However, they can be administered more easily than other demand-side subsidies. Requiring the provider to present a voucher in order to receive the subsidy can prevent irregularities and false claims. If designed well, the voucher can serve as a receipt and a data collection form, as well as a token of exchange. 

Any document used to collect research data on clinical study subjects may be genetically classed as a data collection form. These completed forms provide evidence of the research conducted. The most common type of data collection form is the CRF. Other types of data collection forms include diary cards, dispensing records, quality of life forms, etc. The CRF must allow for proper analysis of the data and proper reporting of the data in the final clinical study report and it must reflect the protocol exactly no more and no less data must be collected. Thus, a CRF must be created for each clinical study and must be prepared in parallel with the protocol. CRFs are usually also prepared by spon-sors/CROs in pharmaceutical industry research because of the demanding requirements for their design and contents. 

The primary purpose of source documents is for the care of the study subject from a clinical perspective the primary purpose of CRFs is to collect research data. CRFs (and other data collection forms) generally cannot substitute as source documents. Data entered in CRFs should generally be supported by source data in source documents, except as specifically defined at the beginning of the study. Nevertheless, some data entered in CRFs may be source data (e.g. multiple blood pressure readings, psychiatric rating scales, etc.) and would not be found elsewhere. This may be acceptable, if these data would not normally be entered in medical records, and if knowledge of such data is not required by the investigator or other clinicians who concurrently or subsequently treat the study subject (the protocol should specify which data will be source data in the CRF). 

ISS) and the integrated summary of efficacy (ISE). These analyses must be planned for just as if the combined database represented data from a new study. It is recommended that plans for meta-ana-lyses will be made at the time the individual studies are planned. This is not always possible, but it is the best way to ensure that the meta-database used for the analysis is coherent. For example, if the adverse events information is collected in two studies using different data collection forms, the combination of the individual databases may be difficult and some information may be lost. 

Other Tools The linkage can be used as a data collection form. Peuts of a LOP ctm be expanded using flow diagrams. The LOP provides a stractuie for using the tools to organize information. 

Planning It is important to have a clear understanding of what we want to learn from the data and who will collect and analyze it. The process of plemning the form may force a more thorough consideration of the issues. Two types of forms ace the check sheet rmd the recording form. Other tools A form for collecting data is often built into other data analysis tools such as a control chart. All of the other data analysis tools will require some sort of data collection form for capturing observations or measurements. 

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