Clr4101 Fundamentals Of Clinical Operations Assessment Answers

Answer:

Introduction

The issue that has been presented in the question is that the meaning of a site audit has been asked. Moreover, the way in which a clinical research site should be prepared for the audit has been explained in this particular study. Furthermore, the authorities that are able to audit the clinical trial sites have also been clarified in this particular study. It should be stated here that it is important to carry out the audit of the clinical trials. This means that the independent and disciplined examination of the activities that are related to the trial and documents of the trial should be properly audited. The audit that is conducted determines the fact whether the activities that are related to the trial and the data or information that has been collected has been accurate and appropriate.

This study aims to explain the significance of a site audit and the objectives of such a process. The preparations that are needed for the purpose of conducting of a site audit has been aimed to be clarified in this particular study (Chambers, Rogers and Boath 2016).

Site audit

The concept of site audit refers to the auditing of the details of a site in which the business activities have to be conducted. It should be stated here that site audit is very important in case of the medical sectors. This is because the quality of the treatment that is provided to the patients depend on such audit of the clinical trials. Therefore, site audit can be referred to as the audit that has been carried out on the premises of any type of business organization or other institutions (Derdeyn caes et al., 2014) .

The purpose of a site audit is to determine whether the site will be able to conduct the clinical trial before the initiation of the investigation. The auditor who is in charge of carrying out the audit of the site has three major objectives, which are as follows:

• Visiting the site by the auditor
• Meeting the staff of the venture
• Inspection of the facilities that have been established

Certain essential points that are mandatorily checked and scrutinized by the auditor are as follows:

• The roles and the responsibilities of the staff and whether they have been competent enough with their roles are to be analyzed
• The procedures of the protocol
• The completion of the CRF and review of the instruction schedule
• The requirements for the management of the records and their retention
• The compliance with the regulations for the handling of the drugs
• The procedures in relation to the enrollment and the consent of the patients
• The expedited adverse event reporting procedure
• The resources that are needed in relation to the recruitment of the patients.
• The identification of the problems and the concerns in regards to the site and ensure that potential solutions are arrived at, post the discussion with the management.

Preparations that are to be taken for a site audit

There are a number of deciding factors upon which the sites for the purpose of audit has been selected. These deciding factors further design the preparations that are to be taken for the purpose of a site audit. These factors can be listed down as follows:

• Enrollment of the patients
• The period of retention of the patients
• The adverse events that might have occurred at the site that has been scheduled for the purpose of inspection
• The importance of the trial is huge

These have been the determining factors, which have led to the conducting of the audit (Mentz caes et al., 2014).

The preparations that should be undertaken for the site audit that has been scheduled can be listed down as follows:

• The entire group of staff should be notified in regards to the date and time of the scheduled audit
• The attendance of the Investigator should be ensured at the time of the audit
• Arrangements should be made for a place that is comfortable and quiet and the documents that will be necessarily required by an auditor should be collected for the purpose of simplifying the work of the auditor.
• The staff of the organization should be properly educated about the details of the inspection process that is going to take place. Moreover, the agenda of the inspection should be clarified to the staff of the organization before the audit of the trial has been conducted.
• The study documents should be collected and gathered at one place. Moreover, the documents should be well organized and complete in nature.
• It should also be ensured that the photocopier machines are accessible so that they can be used when in need. Moreover, a backup of the documents should be created for the purpose of creating a providence of the documents at the time when it is necessary.
• The verification of the fact whether the CRA will be present at the time of conducting the site audit
• The essential documents should also be checked and analyzed before the commencement of the audit. This means that the document related problems that have been reviewed should be remedied before the commencement of the audit. This will ease the work of the auditor.
• Moreover, the CRA should make sure that the essential documents have been verified and reviewed and have been properly placed
• The queries that have not been resolved until the present time should be attempted to be solved before the commencement of the audit
• The agenda of the audit should also be reviewed and confirmed at the site that has been selected for the purpose of inspection.
• Finally, the auditor should develop a plan or agenda for the purpose of carrying out the audit
• The auditor might also engage in the preparation of the working documents that, in all probabilities, are necessary for the purpose of the audit
• The CRA should be notified about the conduct of the audit

Authorities who can conduct site audit

The authorities who can conduct the audit of a clinical research site belonging to a particular business organization can be listed down as follows:

• The administrative body of Food and Drug Administration (FDA)
• The department of the health and clinical services
• The body sponsoring the clinical trial
• The sponsors can be any kind of cooperative groups or the research groups that are based on the grants or the funds that have been provided by the governmental or the non-governmental bodies. An instance can be the medical groups researching the diseases like cancer and the leukemia
• The administrative body of Institutional Review Boards and Protection of Human Subjects in Clinical Trials (IRB)
• Other clinical research institutions

Conclusion

The conclusion that can be arrived at from the above discussed literature is that the importance of site audit particularly in case of clinical research trials is huge. This means that the entire success and the quality of the research depends on the process and the facility in which the clinical trial will be conducted. Therefore, it is very important to conduct the audit of such facility and other related structure for the purpose of ensuring the success of the clinical trial. Moreover, it should be noted here that the success of the site audit depends on the level of cooperation and the preparation that has been undertaken before the commencement of the audit.

References and Bibliogrphy

Chambers, R., Rogers, D. and Boath, E., 2016. Clinical effectiveness and clinical governance made easy. CRC Press.

Derdeyn, C.P., Chimowitz, M.I., Lynn, M.J., Fiorella, D., Turan, T.N., Janis, L.S., Montgomery, J., Nizam, A., Lane, B.F., Lutsep, H.L. and Barnwell, S.L., 2014. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. The Lancet, 383(9914), pp.333-341.

Helgesson, C.F., 2016. From dirty data to credible scientific evidence: some practices used to clean data in large randomised clinical trials. In Medical Proofs, Social Experiments (pp. 57-72). Routledge.

Ivers, N.M. and Grimshaw, J.M., 2016. Reducing research waste with implementation laboratories. The Lancet, 388(10044), pp.547-548.

McFadden, E., Bashir, S., Canham, S., Darbyshire, J., Davidson, P., Day, S., Emery, S., Pater, J., Rudkin, S., Stead, M. and Brown, J., 2015. The impact of registration of clinical trials units: the UK experience. Clinical Trials, 12(2), pp.166-173.

Mentz, R.J., Hernandez, A.F., Berdan, L.G., Rorick, T., O’Brien, E.C., Ibarra, J.C., Curtis, L.H. and Peterson, E.D., 2016. Good clinical practice guidance and pragmatic clinical trials: balancing the best of both worlds. Circulation, 133(9), pp.872-880.

Vose, J.M., Levit, L.A., Hurley, P., Lee, C., Thompson, M.A., Stewart, T., Hofacker, J., Bruinooge, S.S. and Hayes, D.F., 2016. Addressing administrative and regulatory burden in cancer clinical trials: Summary of a stakeholder survey and workshop hosted by the American Society of Clinical Oncology and the Association of American Cancer Institutes. Journal of Clinical Oncology, 34(31), pp.3796-3802.