SOURCE DOCUMENT

Alternate calculations can be made using equations to calculate flue gas compositions and partial pressures of H2O and SO3 to calculate the dew point. The alternate method is shown in the source document also. 

Report accessibility Public domain source documents available - also abstracts... 

Williams, S. M., Ainsworth, R. G., and Elvidge, A. F., A method of assessing the corrosivity of water towards iron , Source document 3, Water Mains Rehabilitation Manual, Water Research Centre/Water Authorities Association (1986)... 

The primary objective of CICADs is characterization of hazard and dose-response from exposure to a chemical. CICADs are not a summary of all available data on a particular chemical rather, they include only that information considered critical for characterization of the risk posed by the chemical. The critical studies are, however, presented in sufficient detail to support the conclusions drawn. For additional information, the reader should consult the identified source documents upon which the CICAD has been based. 

The first draft is usually based on an existing national, regional, or international review. When no appropriate source document is available, a CICAD may be produced de novo. Authors of the first draft are usually, but not necessarily, from the institution that developed the original review. A standard outline has been developed to encourage consistency in form. The... 

The BUSES model has been run for each of the organotins under consideration. This involved developing use patterns for each compound, together with appropriate emission factors (based on the results presented above) and data on the properties of each of the compounds. The data upon which the analysis is based are the usage of each compound by application. More details on the method can be found in the source document (EC, 2003). Regional PECs for fresh water are summarized in Table 16. 

These data have been used to model worst-case exposure for an adult consumer and for a child. Details of the methods and assumptions can be found in the source document (EC, 2003). Table 19 gives the... 

The second improvement comes from the potential that computers have, in conjunction with newer processes, to dramatically reduce the cost and time required to monitor data. Most of monitoring involves comparing a source document, defined as the first place a piece of data was recorded, with what was written. Because data are often recorded by first entry in a patient record,... 

When a user clicks on a typed entity in the Web interface the UltraLink Web Service is called, a connection to the Web Service is established, and the component is accessed. A method named GetLinks is then called together with the following parameters the type of the concept, the normalized form, and the raw text as encountered in the source document (the so-called lemma). 

Per source documents, die s jbjecFs height is 69 inches, but die CRF (KCHt. 002 records 66 inches. Plecsi... 

While U.S. EPA has not promulgated a federal cleanup level for MTBE, some states have established cleanup levels. However, these vary by state, ranging from 5 to 202,000 pg/L, a difference of more than three orders of magnitude.1 Because of the variation in MTBE cleanup levels, after-treatment MTBE concentrations are reported based on information provided in the source documents, and are not compared against a common cleanup level for all projects. 

Verify that the reported trial data are accurate, complete, and verifiable from source documentation. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

The Concise International Chemical Assessment Documents (CICADs) (see Figure 2.3) are similar to the EHC documents in providing internationally accepted reviews on the effects on human health and the environment of chemicals or combinations of chemicals. They aim to characterize the hazard and dose-response of exposure to chemicals and to provide examples of exposure estimation and risk characterizations for application at the national or local level. They summarize the information considered critical for risk characterization in sufficient detail to allow independent assessment, but are concise, i.e., not repeating all the information available on a particular chemical. For more detail, readers of individual CICADs are referred to the original source document for the CICAD (either a national or regional chemical evaluation document) or an existing EHC (chemicals series). 

The protocol should clearly indicate the data that should be present in the medical records as well as in the CRF. For some t)q)es of source data, the CRF is accepted by regulatory agencies as the source document. However, much information will be transcribed from other original documents (e.g. radiological report, medical correspondence, laboratory results and the medical records). 

Source documents are original documents such as medical records, laboratory report sheets, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data... 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

These are small documents that form part of the source documents and are usually fQled in by the subject during a study. They allow the subject to record on a daily basis any modest adverse event, for example, headache, that occurs while taking the new treatment or an efficacy parameter, such as a change in their medical condition. Again, care should be taken in the preparation of the diary so that it is user friendly. It should record days and weeks, not dates, use domestic time, not the 24-h clock, and la)unan s terminology. 

The clinical trial monitor is a temporary member of the site team. A good monitor will conduct scheduled visits, and the investigator and the site staff should provide sufficient time to answer questions and correct data in the CRF that has been transferred incorrectly from source documents. Common errors are omitting negative answers and signatures. The monitor will need space to work and should be provided with requested documentation, including medical records, for review. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

Is there sufficient source documentation to indicate that the study subject existed ... 

Many scientists confuse the terms QC and QA. In terms of clinical trials, there is a very real difference. QC is the operational techniques and activities undertaken by all participants to verify that the quality requirements of the clinical trial have been fulfilled whereas QA verifies that the QC has satisfied these requirements. In other words, QC is where the data recorded is checked with source documents, and that measurements and procedures followed are those described in SOPs and the protocol. QA is where independent individuals establish that QC is in place and report any deficiencies without bias. 

Many investigator sites employ part- or fulltime nurses to support the clinical trials. Nurses should never be considered to be an extravagance, because without them, the onus of administration and QC is solely on the investigator. The clinical trial nurse can help the investigator in many ways, but two of the most important are ensuring that the CRT reflects what is present in the source documents, such as essential events of the medical history of the subject, and close liaison with the sponsor s monitor. 

With respect to leaflets, all information given must be approved by the Agency with final versions being sent on confirmation. Leaflets must not be promotional and must be consistent with the product hcence, which will be the source document for assessment of the PIL. The information required is given, together with extensive footnotes in the guidance prepared by the Agency. Areas of interpretation where difficulties may arise are as follows. 

The investigator should prepare an informed consent form for every study to be performed at the institute and should obtain an approval by the IRB that covers the institute. GCP listed a dozen points to be covered by the informed consent (1C) form (see Table 23.6). The new GCP allows a reasonable amoimt of pa)unent to the patient, such as transport cost. Patients should allow clinical trial monitors, auditors, IRB members and inspectors from the regulatory authority to verify the source documents. This new requirement of obligatory written 1C is regarded as a... 

CII (Constmction Industry Institute). 1992. Source Document 80, Project Performance Modeling A Methodology for Evaluating Project Execution Strategies. Prepared for CII by David B. Ashley and Luis Fernando Alarcon-Gardenase. Austin, Tex. Construction Industry Institute. 

Bijlefeld, Marjolijn, ed. The Gun Control Debate A Documentary History. Westport, Conn. Greenwood Press, 1997. A collection of more than 200 primary source documents relating to gun control issues. Includes historical, constitutional, legal, and legislative aspects of gun regulation. 

In this handbook you will discover 901 existing innovative and emerging solutions to contaminant problems. Each technique features a carefully worded yet brief summary of the technology written by specialists in the field in collaboration with talented technical editors. Each is accompanied by technical and cost performance reports, source documents, and the vendors that may specialize in the various applications. 

Periodic monitoring of the consistency between database and source documents (e.g., direct comparison for a random sample of the records)... 

U.S. Army Biomedical Laboratory. Evaluation of EA 4923 for mutagenicity and chromosome damaging potential. IN EA 4923 - A volatile Sensory Irritant, Part 2 - Source Documents. Edgewood Arsenal, Md. November 8, 1977. p. 217-223. 

FDA investigators compare information that clinical investigators provided to sponsors on case report forms with information in source documents such as medical records and lab results, says Carolyn Hommel, a consumer safety officer in DSI. 

The Instrumental Criteria Sub-committee of the Analytical Methods Committee has been active for many years in producing Guidelines for the Evaluation of Analytical Instrumentation. Since 1984, they have produced reports on atomic absorption, ICP, X-ray spectrometers, GLC, HPLC, ICP-MS, molecular fluorescence, UV-Vis-NIR, IR and CE. These are excellent source documents to facilitate the equipment qualification process. A current listing of these publications is given in Section 10.2. 

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