Before Study
Study documents are very crucial for good clinical practices. Like any other scientific study, a clinical study has a number documents that need to be filled before, during and after study to help in the success and straightforward review of the research. These documents facilitate audit and inspection of the study procedures, results, and recommendations by any person or by the health regulatory authorities. Two parties are involved in the filling of these documents, the investigator, and the sponsor.
Through these documents, authorities are in a position to validate the study and integrity of the data collected. With regard to good clinical practices and regulatory requirements, compliance with these documents is necessary. Compliance will not only permit the conduct and evaluation of the trial but will also help in a significant way in the successful management of the clinical study. This paper, therefore, focuses on the necessary documents required before, during and after a clinical trial/study. Management of these document is possible with a trial master file1.
These documents facilitate the planning of the study. They should, therefore, be filed in the trial master file before the commencement of the trial. The documents are as discussed below.
Investigator’s brochure. The purpose of the document is to note or identify any current scientific information that is relevant to the study or investigational product provided to the investigator. In other words, the brochure contains pre-clinical and clinical information regarding the product under investigation2. The information is presented in a simple, concise and objective form.
Trial protocol, and sample case study. The case study is not mandatory but depends on whether there are previous studies conducted on the given product or topic. It, therefore, means that a case study should be presented if and only if there are previous works. The purpose of the trial protocol is to document any agreement made between the investigator and the sponsor relating the trial2. Amendments are provided to record the course taken by the study from the initial plan.
Information consent form. This should be approved by the institutional review board (IRB) where applicable. It is a form of agreement indicating that subjects or parties concerned with the study will be issued with appropriate written information to aid them in making their informed consent after the review3.
Financial and insurance statements. The financial statement outlines the agreement between the investigator and the sponsor regarding the cost implications of the study while insurance statement outline the form of compensation to be provided to the investigator and other staff in case an accident or injury occur during the running of the trial.
During Clinical Study
Signed agreement between involved parties. This document shows agreements settled between the investigator, the sponsor, and the institutional review board along with IRB’s composition. The aim of the document being a means to portray the knowledge and approval of all involved parties.
Medical Laboratory procedures, sample labels, and instructions regarding handling of the investigational product. First, the document should indicate the competence of the facility from which the study or trial will be conducted from4. Competences go hand in hand with certification or accreditation. Secondly, illustrate the labeling of the investigational product containers with the aim of demonstration appropriateness and compliance with the applicable labeling policies/regulations. Thirdly, the document should in details demonstrate the storage, packaging, dispensing and the disposition details or instruction about the clinical study product5.
Records of trial related materials and products. This document outlines all the materials required for the study, their batch numbers and any other relevant information that can aid in tracking them down in the course of the study. If the products are to be purchased or shipped, the information will be captured in this document.
Pre-trial and trial initiation monitoring reports. A pre-trial report shows the suitability of the site in the conducting of the study whereas the trial monitoring report aims at showing that the trial procedures have been reviewed by both the investigator and the trial staff.
As at this stage, requirements for the study are identified and addressed. Using the trial master file, the following documents need to be filed as new and relevant information becomes available. Most documents are as used before trial but need to be updated.
Investigator’s brochure updates. Before the trial, a brochure was developed to capture previous study data. However, during the study, new information and data relating the trial will emerge. The previous brochure will be updated with this new information6.
Revision/amendments to protocol, case study, and information consent form. Things do not always work out as planned. For this reason, revisions and amendments will need to be recorded and filed to show the course of the study from pre-trial, initiation to study completion.
Updates on medical/laboratory procedures and instructions. As mentioned above, any changes from the planned should be recorded, documented and filed. The same applies to changes in the procedures and instructions during the study. It is worth noting that any revision, change or amendment should be communicated to the relevant parties for approval7 where possible. This helps bring the parties at par with the study as is conducted by the investigator.
After Completion of the Study
Monitoring visit reports. In the course of carrying the study, the investigator will likely make site visits. This document details the visits and the findings made by the monitor or the investigator. Other communications or findings gathered out of the site visits, like letters, meeting discussions and notes from telephone conversations should also be documented.
Source documents and a signed and dated case report form. The main aim is to substantiate the integrity of the data collected as well as acknowledge the source documents related to the study. The case report form should be signed as a confirmation of the correctness of the observations made.
Notification about safety or adverse safety event. As mentioned above, accidents are bound to occur if care is not exercised. This document outlines and notifies either the investigator, the sponsor, or IRB of the safety or serious events witnessed during and at the course of the study8. Pursuant to the insurance statement, the respective parties become well aware of the compensation or the way forward.
Subject screening, identification and enrollment logs. The purpose of the document is to outline the persons who were subjects to the study. The information should, however, be kept confidential as stated in the information consent document. Where possible the arrangement of the subjects should be in chronological orders to aid in the analysis and audit after the completion of the trial.
Progress report and a signature sheet. In the course of doing the study, the investigator should provide an interim trial report to the relevant parties to illustrate achievements and challenges faced. Along with this report is a signed signature sheet with initials of all relevant persons confirming the correctness of entries made in the report.
As at this stage, all the above documents should be filled and filed. This is to help pave the way to the completion of the study. Below are the documents required at the termination of a trial.
Product accountability form. When conducting the study or trial, the relevant material was issued to the investigator. After completion of the trial, the remainders need be returned to the sponsor. This document, therefore, monitors that investigational product was used in line with protocol, in right quantities with remainders returned to the sponsor and destroyed where necessary9.
Complete subject identification list. At the end of the trial, the investigator and his staff should compile a code list of all the study subjects. This is to allow the easy identification of all the subjects enrolled in for the study in case there is the need for follow-ups. As mentioned above, this list should remain confidential according to terms outlined in the information consent form.
Audit certificate. This document confirms that audit to the study was performed by the relevant body to ascertain compliance and validity of the study report10.
Final trial close-out monitoring sheet. During the study, several issues and actions emerge. These issues and events need to be closed out to pave the way for the preparation of the final report regarding the study. (11) This document outlines the issues and action taken to phase them out.
Clinical study report. Having closed out all actions about the study, obtained relevant data and filled the necessary study documents, the investigator provides the final study report clearly illustrating the results together with their interpretation. This report is shared with all the parties involved12.
Conclusion
Documents are very crucial in a clinical study because they facilitate future referencing. From the outgoing discussion, the list appears enormous, however, it is allowed to combine one, or the other document provided the individual elements in these documents remains identifiable. To easily manage the documents a trial master file is used where documents are filed as they emerge. Worth remembering is that the final close-out sheet for the trial should only be done once the investigator, the sponsor, and any other party are certain and satisfied with all the other documents. Failure to do this will leave some actions not closed out. Finally, all the documents should be available for audit by the sponsor, IRB or any of the regulatory authorities.
References
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