Source data, documentation

Direct access to source data/documents AU medical records available... 

The sponsor is responsible for securing agreement from all involved parties to ensure direct access (see 1.21) to all trial related sites, source data/ documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities. 

The following techniques can be used to collect data about human performance in CPI tasks and provide input to task analysis methods described in Section 4.3. These data can include process information critical for the task, control strategies used by the workers, diagnostic plans etc. A distinction can be made among data collection methods that provide qualitative data (such as interviews, observations, and sources of documentation) and methods that can be used to measure aspects of performance (such as activity analysis, simulations, and information withholding). The latter methods can provide more precise data which can be quantified. 

CRAs achieve these tasks through frequent visits to the clinical trial site. During these visits, the monitor will verify source data, audit regulatory documents for accuracy and completion, perform drug accountability assessments, and communicate any concerns, problems, or new information with the study staff. 

AU the medical records of the subject should be available for comparison with the data recorded in the case report form (CRF). In the past, physicians have not allowed medical records to be available for the so-called source verification by non-physicians since they felt that this broke the strict confidentiality of the study subject s medical records. However, frequent mistakes in transferring important clinical data to the CRF, the recruitment of subjects who do not meet the inclusion and exclusion criteria and the occasional blatant fraud has led to an insistence by sponsors and regulatory agencies for sponsor s review of study documentation. Indeed, verification of source data cannot take place without access to the medical records of the study subject by the sponsor s staff. 

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). 

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... 

As well as GCP site inspections, an examination is imdertaken of the raw or source data and records of Chemistry Manufacturing and Control (CMC), non-clinical and clinical reports that are the basis of the application. This is to ensure that the application dossier accurately reflects the source data. The procedure issued by PMDA details that list of raw data and records must be provided. The applicant is required to bring the data and records to PMDA on the specified days and when the examination finishes they should be retrieved. Therefore, the raw data and records stored at overseas sites are usually categorised as documents not to be submitted and not subject to reliability review by PMDA. Instead, the MHLW may investigate the data from non-Japanese studies at the site of storage since submission of a photocopy of the data is not permitted. 

Data source BLA document published by CBER for Rebif (2002). 

Ketamine became a controlled Schedule III substance in August 1999 based on DEA data documenting the growing abuse of this drug. The marketed forms of ketamine—Ketalar (for human use) and Ketaset, Ketajet, and Vetalar (for veterinary use)—are available only to licensed medical and veterinary personnel. Clandestine manufacture of ketamine has not been encountered because, in contrast to that of PCP, the synthesis of ketamine is a complex and time-consuming process. For this reason, the vast majority of ketamine distributed in the United States is diverted or stolen from legitimate sources, particularly veterinary clinics. 

Archiving of software and documentation What is archived, for how long (software, revisions, source code, documentation) Where is the source code archived Can the source code be made accessible to regulatory agencies Is a periodic check of data integrity ensured ... 

Source data verification is the process of verifying CRF entries against data in the source documents. Source data verification is only carried out at the study site, usually by the sponsor/CRO monitor (auditors will also conduct source data verification on a sample of CRFs inspectors may conduct source data verification on a sample or all CRFs). 

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... 

Source documentation-source data, as defined in the ICH Guidelines 1.51, is all the information in original office or hospital records, and certified copies of original records of clinical findings, observations, and other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Original data is contained in source documents. 

Data from several sources as documented in a report by the NAS. ... 

The 90th Edition of the CRC Handbook of Chemistry and Physics marks a milestone for this reference work, which first appeared in 1913. For almost a century the Handbook has been updated annually, except for a few wartime years, and has served several generations of R D professionals, engineers, and students. Its aim has always been to provide broad coverage of all types of physical science data commonly encountered by scientists and engineers, with as much depth as can be accommodated in a one-volume format. The data contained in the Handbook have been carefully selected by experts in each field quality control is a high priority and the sources are documented. The annual updates make it possible to add new and improved data in a timely fashion, and references to more detailed data sources have helped to establish the Handbook as the first place to look for physical and chemical data. 

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). 

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