Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials

2009 ◽  
pp. 15-62
Keyword(s):  
Case Report ◽  
Informed Consent ◽  
Standard Operating Procedures ◽  
Consent Form ◽  
Clinical Protocols ◽  
Study Research ◽  
Informed Consent Form ◽  
Standard Operating

scholarly journals Pelaksanaan Informed Consent pada Pemeriksaan Intra Vena Pyelografi di Instalasi Radiologi Rumah Sakit Umum Sukoharjo

2017 ◽  
Vol 3 (1) ◽  
pp. 199-203
Author(s):  
Rini Indrati ◽  
Meita Shinta Fatikhatul Laila ◽  
Andrey Nino Kurniawan
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Consent Form ◽  
Radiology Department ◽  
Medical Council ◽  
Patient Understanding ◽  
Informed Consent Form ◽  
Descriptive Qualitative

Background: The implementation of informed consent at Radiology department of Sukoharjo Hospital was conducted by administrative officer and radiographer. The officer explained the preparation of pyelographic intra-venous examination to the patient then the patient was asked to fill out and sign the informed consent form. According to the Indonesian Medical Council and Regulation of the Minister of Health of Indonesia, the delivery of informed consent is carried out by doctors. The doctor explains all the information contained in the contents of informed consent before taking any medical action. The purpose of this research is to know the implementation of informed consent done in the radiology department and patient understanding of the contents of the informed consent form.Methods: The type of this research is descriptive qualitative research with the observational approach. Data were collected in March-June 2017 by observational of informed consent and interviews of 30 patients who will conduct intra vena pyelographic examination. Data analyzed by descriptively.Results: The results showed that the provision of informed consent to intravenous pyelographic examination patient at Sukoharjo Hospital was performed by administration officer and radiographer before conducting the examination. The patient's understanding of the contents of informed consent has not been in accordance with the content of the informed consent form because the information submitted by the radiologist only concerning the preparation of intravenous examination of pyelography does not include examination procedures, objectives, risks, complications, diagnoses, prognoses, alternative other measures and risks, and costs.Conclusions: In radiology department of Sukoharjo hospital at Intravenapyelography patient informed consent delivered by administrative officers and radiographer. Patients understanding the content of informed consent

Usability Testing

2001 ◽  
Vol 9 (2) ◽  
pp. 15-20
Author(s):  
Susan Waters ◽  
Melody Carswell ◽  
Eric Stephens ◽  
Ada Sue Selwit
Keyword(s):  
Informed Consent ◽  
Usability Testing ◽  
Consent Form ◽  
Research Project ◽  
Informed Consent Form ◽  
The Difference

How information is presented in an informed consent form can mean the difference between success and failure in a research project.

OHP-008 Waste in biomedical research due to informed consent form deficiencies

2017 ◽  
Author(s):  
E Villamañán ◽  
I Jiménez-Nácher ◽  
P Gómez-Salcedo ◽  
E Wagner ◽  
M Freire ◽  
...  
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Consent Form ◽  
Informed Consent Form

scholarly journals Informed surgical consent during the COVID‐19 pandemic: Exploring the risk of unknown—Update of informed consent form

2020 ◽  
Vol 122 (6) ◽  
pp. 1259-1259
Author(s):  
Alberto J. A. Wainstein ◽  
Ana P. Drummond‐Lage ◽  
Reitan Ribeiro ◽  
Heber S. Castro Ribeiro ◽  
Rodrigo N. Pinheiro ◽  
...  
Keyword(s):  
Informed Consent ◽  
Consent Form ◽  
Informed Consent Form
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