Clinical Research: Site Audit Preparations and Responsible Bodies

This report provides a comprehensive overview of clinical research site audits, emphasizing their significance in ensuring the quality and success of clinical trials. It defines site audits as independent examinations of trial-related activities and documents, aiming to verify data accuracy and adherence to protocols. The report outlines the objectives of site audits, including evaluating site readiness, staff competence, and facility inspection. It details the necessary preparations for a site audit, such as informing staff, gathering essential documents, and addressing outstanding queries. Furthermore, the report identifies the authorities responsible for conducting these audits, including the FDA, health departments, trial sponsors, IRBs, and other research institutions. The conclusion stresses the critical role of site audits in clinical research and highlights the importance of cooperation and thorough preparation for a successful audit process. The report is a valuable resource for understanding the intricacies of clinical research site audits.

Running head: CLINICAL RESEARCH
Clinical Research
Name of the Student:
Name of the University:
Author Note

1CLINICAL RESEARCH
Table of Contents
Introduction......................................................................................................................................2
Site audit..........................................................................................................................................2
Preparations that are to be taken for a site audit..............................................................................3
Authorities who can conduct site audit............................................................................................5
Conclusion.......................................................................................................................................5
References and Bibliogrphy............................................................................................................6

2CLINICAL RESEARCH
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:

3CLINICAL RESEARCH
 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

4CLINICAL RESEARCH
 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

5CLINICAL RESEARCH
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.

6CLINICAL RESEARCH
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.