China
Africa
Explore chapters and articles related to this topic
The role of routine enhanced audit
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
The sampling level, which is the standard method for routine audits, must also be defined in the audit plan. This assists the auditor in making an accurate estimation of the required time to conduct the audit at the site. Most routine audits are successfully conducted by two auditors at a site for two days. During this time, it is likely that only eight case report forms (CRFs) may be reviewed fully against the source data, but this will of course depend on both the size and complexity of the study and the associated CRF.
Clinical Trials in Ayurveda
Published in Saroya Amritpal Singh, Regulatory and Pharmacological Basis of Ayurvedic Formulations, 2017
A document designed in consonance with the Protocol, to record data and other information on each trial subject. The Case Record Form should be in such a form and format that allows accurate input, presentation, verification, audit and inspection of the recorded data. A CRF may be in printed or electronic format.
Anterior thalamic nucleus stimulation: issues in study design
Published in Hans O Lüders, Deep Brain Stimulation and Epilepsy, 2020
To minimize chances of a complication from MRI, and to obtain approval of the FDA to perform MRIs, the study sites agreed to adhere to the following protocol: Verification that necessary clinical information cannot be obtained by a computed tomographic (CT) scan. The principal investigator will document this in each case, on a case report form, that the necessary information is not obtainable in that patient from a CT scan.Performance of the magnetic resonance image (MRI) scans on the same GE Signa scanner at each center.At each center, prior to performing the first scan on patients implanted as part of this protocol, a set of unimplanted deep brain stimulation (DBS) leads and a Kinetra stimulator will be held in the strong field of the MRI coil, to document lack of magnetic attraction and no tendency to move in a magnetic field.The Kinetra stimulator will be turned off by setting the voltage to zero prior to any scans.If a scan is done prior to tunneling the DBS leads, the external ends of the DBS leads will be individually wrapped prior to the performance of the MRI, to prevent inadvertent closed electrical circuits.Patients will be instructed to report any unusual sensations during the scan, which will result in termination of the scan and re-assay of the settings of the stimulator.Within two working days of completion of the MRI, the programming console will be used to verify that the stimulator is on and set to proper protocol voltage of either 5 or 0 volts.
Extension for community Healthcare Outcomes (ECHO) chronic pain & opioid stewardship in northwestern Ontario: A thematic analysis of patient cases
Published in Canadian Journal of Pain, 2022
Patricia A. Poulin, Yaadwinder Shergill, Adrian Grebowicz, Inês Almeida, Rosemee Cantave, Bryan MacLeod, Tim Larocque, Donna Garstin, Sarah F. Fitzgerald, Joshua A. Rash
Project ECHO-SJCG’s Hub consists of specialists with expertise in the management of CP who are based at St. Joseph’s Care Group in Thunder Bay (Ontario, Canada), and at The Ottawa Hospital in Ottawa (Ontario, Canada). The Hub offers weekly 90-minute sessions to HCPs who are interested in learning about managing CP in their practice and includes a didactic presentation as well as a 45-minute case discussion. Cases are submitted by participants in advance by completing a detailed form with non-identifying information about their patient (case report form). During the case discussions, both participants and Hub members are invited to ask questions and offer their perspective on the case presented. A Hub member records the key learning points about the case on a case summary form which is subsequently (within 1 week) reviewed by all members of the Hub to ensure that it accurately reflects what was discussed before being shared with the presenting HCP and stored on the Hub website. Because Project ECHO-SJCG case discussions are not clinical consultations, we use the term “key learning points” to refer to the key ideas that are recorded about the case discussions.
The order of administration of macrolides and beta-lactams may impact the outcomes of hospitalized patients with community-acquired pneumonia: results from the community-acquired pneumonia organization
Published in Infectious Diseases, 2018
Paula Peyrani, Timothy L. Wiemken, Mark L. Metersky, Forest W. Arnold, William A. Mattingly, Charles Feldman, Rodrigo Cavallazzi, Rafael Fernandez-Botran, Jose Bordon, Julio A. Ramirez
This was a secondary analysis of patients enrolled in the Community-Acquired Pneumonia Organization (CAPO) international cohort study and included cases collected between 2001 and 2016 [16]. The CAPO study is an international, retrospective, cohort study where patients are followed since admission to the hospital up to discharge and then a final assessment is made at 30 days if information is available in the medical records. In each participating centre, non-consecutive medical records of hospitalized patients with the diagnosis of CAP are reviewed. Data regarding demographics, comorbidities, diagnostics, management and outcomes for the entire hospitalization are collected in a case report form. A sample of this data collection form is available at the study website (www.caposite.com). Institutional Review Board approval was obtained by each participating centre.
Long-term outcomes and predictors of a large cohort of idiopathic retroperitoneal fibrosis patients: a retrospective study
Published in Scandinavian Journal of Rheumatology, 2019
A standardized case report form was used for data collection. Age at diagnosis, gender, dates of disease onset and definite diagnosis, symptoms of disease onset, presence of hydronephrosis at baseline, time of noticing renal atrophy (at baseline or during follow-up), date of last follow-up, renal function and vital status at last follow-up, and smoking status were included in the forms. Baseline laboratory data included complete blood cell count, creatinine, CRP, ESR, and immunoglobulin G4 (IgG4) levels. Imaging findings at diagnosis were abstracted by reviewing the radiology reports. For patients who had undergone biopsy, the pathology reports were reviewed.