Site Auditing

Question: What is a site audit and explain how a clinical research site must prepare for an audit? Which authorities can audit clinical trial sites? Answer: Introduction In a clinic auditing is essential as it oversees the progress of a clinical trial that takes into account the Standard Operating Procedures, Applicable regulatory as well as Good Clinical Practice (Hay, 2014). In addition to this, site auditing is also done for ensuring that the rights of the human beings are well protected or not. This assignment will be dealing with the site auditing, preparation of auditing by clinical research site and authorities that audit the clinical trial sites. Site Audit Site auditing is a systematic as well as an independent process that is concerned with the activities ad documents that are required for analyzing the data that is been recorded. It is done according to the requirements, GCP as well as sponsors SOPs (Kilgore, 2014). The auditors are the independent trial teams that are trained for auditing the clinical sites and are bounded by the regulatory bodies. The auditors are the independent trial teams that are trained for auditing the clinical sites and are bounded by the laws and rules (Mayorga, 2013). Preparation of audit by a clinical research site For auditing the clinical research site, the auditor has to do preparation that includes the following responsibility of the management, procedures regarding their adequacy, training, changing control, internal monitoring program, documentation control as well as deviations. In addition to this, Lenz and Sarens (2012) commented on the fact that the for preparation of the audit, the auditor of the clinical research site also keeps a focus on the manufacturing, labeling, packaging as well as coding of the product. The audits are so prepared that it highlights the problems of the clinical sites that are identified as well as corrected. This is because, on the basis of that the correct and preventive measures are taken for improvement of the overall quality. Apart from this, Hay and Toy (2014) had a view that the clinical site auditors also prepare audits that includes the essential documents. These include the brochure of the investigator, signed protocols, and financial aspects, amendm ents, insurance statement etc. that are essential in the auditing function. The essential documents contain case report forms, signed sheets, corrections of CRF, identification of code list, serious reports of adverse events etc (Ramanan, 2014). Along with this, Litt et al. (2013) had an opinion that the certifications of the labs, the regulatory authorization of the authorities, normal value of the laboratory tests etc ate also included in the preparation of the audit report by the clinical site. According to Bigus (2012) the requirements such as shipping records, the trial site accountability, certificates regarding the analysis of the shipped products are also explained thoroughly. The research audit of the clinical site also contains the information regarding the laboratory test. This includes the receipt as well as storage of samples, qualification of the instruments that are required and the methods of handling the solutions and the reagents. Daff (2012) commented that keeping all these information in mind, the other requirements needed are the computerized systems that is necessary for maintenance, achieving, retrieving as well as transmitting the data. This also takes into account the security of the system, traceabi lity, retention capabilities, validation status etc. Moreover for a successful preparation of the audit, the clinical site also needs to have a strong data backup system, contingency plans, recovery system as well as personnel training system (Hay, 2014). Another major issue that is included in the audit report is the safety measures that the clinical sites has undertaken for the safety of the doctors, nurses and other medical and non-medical staffs and patients. Moreover the integrity of data s well as maintenance of proper database is also essential to maintain. Authorities that audits clinical trial sites The clinical trial sites have a handful of authorities that audits the clinical trial sites for verifying the accuracy rate as well as reliability of the data that are submitted by the agency. The FDA investigator oversees whether the clinic is complied with the rules and regulations during its operation (Kilgore, 2014). In addition to this, The Department of Health and Human Services (OHRP), the sponsors, the Cooperative groups and IRBs are the authorities that are responsible for auditing the clinical trial sites. These concerned groups are concerned about the safety, ethics and maintenance of clinical standard within the clinics (Hay and Toy, 2014). Conclusion This assignment has discussed vividly regarding the site auditing, the authorities that are concerned with it the preparations of the clinical sites for getting themselves prepared for auditing. The system, documentation as well as maintaining the clinical sites to operate ethically are also discussed. References Bigus, J. (2012). Vague Auditing Standards and Ambiguity Aversion. AUDITING: A Journal of Practice Theory, 31(3), pp.23-45. Daff, L. (2012). The ethics application. Acc Auditing Accountability J, 25(3), pp.570-571. Hay, D. (2014). Auditing, International Auditing and the International Journal of Auditing: Editorial. International Journal of Auditing, 18(1), pp.1-1. Hay, D. and Toy, A. (2014). Privacy Auditing Standards. AUDITING: A Journal of Practice Theory, p.141231081701003. Kilgore, A. (2014). Audit quality. Managerial Auditing Journal, 29(9). Lenz, R. and Sarens, G. (2012). Reflections on the internal auditing profession: what might have gone wrong?. Managerial Auditing Journal, 27(6), pp.532-549. Litt, B., Sharma, D. and Sharma, V. (2013). Environmental initiatives and earnings management. Managerial Auditing Journal, 29(1), pp.76-106. Mayorga, D. (2013). Managing continuous disclosure: Australian evidence. Acc Auditing Accountability J, 26(7), pp.1135-1169. Ramanan, R. (2014). Corporate Governance, Auditing, and Reporting Distortions. Journal of Accounting, Auditing Finance, 29(3), pp.306-339.