Patient record

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,... 

There has been a push for direct data collection (DDC) as an alternative to remote data capture (RDC). In this approach most of the required clinical data are acquired directly from existing patient record systems such as MRI machines, ECG, EEG, TTM, laboratories, and other measurement equipment. This approach eliminates the need for paper transcription and reentry to another system. It promises error-free and resource-efficient data capture, which allows early locking of the database and therefore potentially earlier product launch [30]. 

Most workshop participants recommended that data to be used to support drug safety and efficacy for registration should have a link to the patient record. In addition, samples linked to patients data have potential for use in subsequent validation studies that are unanticipated at the outset of drug development. 

Aside from 1,300 patients recorded in Japan during 1976-1982, more than 5,000 DSP cases were reported in Spain in a single year of 1981... 

Procedures are in place to restrict access to data and records to appropriately authorized persons. Confidential patient records, of course, dictate their own security standards. This form of confidentiality is largely an issue in chnical research, but may impact upon some laboratory environments. Of greater concern here are issues of access related to the potential to modify or delete laboratory records, either through accident or fraudulent intent. A combination of protected audit trails (see below) and read-only electronic controls can assure appropriate restriction. 

GMP requires a massive amount of recordkeeping. Records prove that GMP guidelines are being followed. Although the burden of documenting all facets of manufacturing may seem excessive, records help ensure the quality of an API and safety of both employees and patients. Records also help to track down problems if an issue arises. 

Physical facility A patient service area distinct from the dispensing area will be created. The space will use cubicle dividers to allow privacy to perform the tests and to allow the education and counseling sessions. The space will be large enough to fit the equipment, a desk or table, chairs, and a computer. A patient record system that can interface with the dispensing software will be used. 

The documentation will occur via a patient chart. Subjective patient information and objective laboratory data will be stored in the chart. Assessments of patients during the clinic visit will be documented in pharmacy progress notes contained in the chart. Acceptance of pharmacy recommendations by physicians will constitute an order change, and this will be documented in the patient record as well. Lasdy, patient... 

After speaking with the pediatrician, you do some checking in Mabel s patient record, and you discover... 

Complete Patient Records (case forms) should be included, with any gaps clearly indicated and discussed. The natural FDA assumption is that any missing case record form represents either (a) an adverse reaction, (b) sloppy procedures, or (c) an attempt at fraud. Clearly document the reason for any missing case form, including the results of a Quality Assurance follow-up investigation. 

There are, however, exceptions to the washout period conditions. For example, if a patient exhibits symptoms of sufficient severity to warrant not withholding treatment, this patient may be entered into the study even though the washout period is less than that specified. If a note to this effect is included in the protocol, the investigator should provide ample justification in the comment section of the case report form. In the monitoring of a study, patient records should be carefully checked for validity (acceptability) of the reasons for exemption from the full washout period. 

The CRAs should have spotted any illegible items on patient records and, by interviewing the clinician, restored the information before it was forgotten. 

Well-managed and maintained longitudinal patient records... 

Clinical phenotypes are predominantly described at a categorical level. Clinical phenotypes as we can find them in patient records are rarely found in scientific publications.33... 

FIGURE 7.7 Workflow of an application of SAS Text Miner for the classification of clinical patient records containing Diagnosis Related Group (DRG) codes. 

A phase III study was conducted to compare PEG-liposomal DXR (50 mg/m2 every 4 weeks) with paclitaxel (175 mg/m2 every 3 weeks) using 214 patients with relapse after first-line platinum-based chemotherapy [420], As previously, the response rates and PFS were not significantly different, but again the liposomal formulation was notably less toxic as fewer patients recorded with grade 4 adverse effects (17% compared to 71% for topotecan) and thus was more tolerable. 

Remote approval of Certificates of Analysis at contract laboratories Updates, exchange and approval of training records and SOPs Administration of electronic patient records... 

Of the commonly used therapeutic drugs, the greatest risks are encountered when clinicians prescribe topical steroids (for extended periods), systemic steroids, P blockers, miotic antiglaucoma agents, and oral carbonic anhydrase inhibitors (CAIs). Optometrists should be aware of the adverse effects that attend the use of these drugs and should warn patients accordingly. Disclosures should be documented in the patient record. 

In clinical situations for which alternative treatments exist, optometrists should note in the patient record that the alternatives were discussed and that the treatment chosen was obtained with the patient s consent. 

Optometrists have a similar duty to discuss the results of diagnostic tests with patients and to advise patients of the availability of further testing to rule out the presence of disease. Ambiguous or suspicious findings should be resolved, and if patients do not return for recall appointments or do not wish to undergo further evaluation, these facts should be documented in the patient record. 

Communications with patients required by the doctrine of informed consent should be documented in the patient record. Either a handwritten entry or a form signed by the patient is adequate for legal purposes. Failure to record communications or inadequate entries concerning such communications may result in a successful legal claim against the practitioner. 

In rare cases the matter may be of such importance that a certified letter, return receipt requested, should be sent to the patient, with a copy retained in the patient record. By whatever means selected, optometrists should not overlook the necessity for documentation in these cases. 

Patients may be affected by photophobia and loss of accommodation, as they are with mydriatics.Therefore patients must be monitored while in the office and on the premises and must be warned of the drug s effects while operating a vehicle or performing other tasks that pose a risk of injury to patients or others. Documentation of this warning should be included in the patient record. 

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