Clinical trials documentation data collection

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

Regulations also exist to protect the confidentiality of the research participant. All information collected throughout the clinical trial remains with the study staff. For the purposes of data capture, each subject is identified by initials or study number only. In addition, the informed consent discusses who will have access to the trial documents. 

CHMP (2005) Guidance on Data Monitoring Committees/ FDA (2006) Establishment and Operation of Clinical Trial Data Monitoring Committees These documents provided guidance on the set up, operational and working procedures, and the roles and responsibilities of the DMC in a single clinical trial or collection of trials (see Section 14.4). 

Case report forms (CRFs) are used throughout clinical trials to record data collected during a trial. They record all of the information specified in the protocol for each subject (all data recorded on the CRF must be verifiable from original source documentation). While the traditional paper CRF format is still used, electronic data collection is becoming more common. Voorhees and Scheipeter (2005) discussed CRF development in detail, highlighting some of the fundamental aspects of their purpose, design, and nature ... 

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit the rules and special requirements from the statistician, clinician, safety officer, medical writer and regulatory associates. These project materials, rules and special requirements will be considered in conjunction with data management requirements to develop the data management plan. The CDC should prepare the following documents before the clinical trials are initiated ... 

The previous sections have described how a clinical trial is designed, the documentation that must be prepared, and the preparation, documentation and dispatch of clinical trial material. None of these areas should be carried out in isolation and need to be addressed long before the first study subject is recruited. The pharmaceutical physician cannot be responsible for all these tasks unless he or she is carrying out independent research. Even then, he or she should seek expert help in the design of the study in relation to the statistical analysis and how the data will be collected and entered onto a database. 

In addition to data on the effects of /S-blockers on survival, there are data showing improvements in numerous other end points. All the large clinical trials have shown /3-blockers to produce 15% to 20% reductions in all-cause hospitalization and 25% to 35% reductions in hospitalizations for worsening heart failure. The positive effects of -blockers on the left ventricle systolic function also have been very consistent across studies. Following several weeks to months of therapy, /3-blockers have been documented consistently to increase EEs by 5 to 10 units (e.g., from an EF of 20% to 25% or 30%), to decrease ventricular mass, to improve the sphericity of the ventricle, and to reduce systolic and diastolic volumes (LVES V and LVEDV). These effects are often collectively called reverse remodeling, referring to the fact that they return the heart toward more normal size, shape, and function. 

Careful documenfation is always very important since the report on a trial is usually written a long time, sometimes years, after the first patient is entered. The study protocol therefore serves not only as a basis of decisions made during the trial but also as the source of those decisions. The protocol is also important since clinical investigators may change or new ones join the study. In fact, a protocol should be written clearly in order to help researchers to repeat the trial elsewhere. All documents (including patient data collecting forms) should be kept for a long time to provide the possibility to reanalyze the trial if needed. 

Audit notes are indispensable to allow QA auditors to write an accurate report after the audit. Detailed notes allow the auditor to prepare a meaningful audit report which is based on verified observations. All information collected during an audit is considered audit evidence. Information sources in an audit are, for example, document review, interviews and observation of activities. If applicable, sampling techniques may be applied, for example for SDV and verification of information in tables and listings. Audit observations are only considered audit findings if it is determined after comparison with audit criteria that these are not or insufficiently fulfilled. And finally, audit conclusions can be drawn to assess whether the audit findings impact the validity of the clinical data and the safety of the trial subjects. 

---