Logs should be study-specific with the study title and PI located at the header. Not all logs will apply to every study, but when applicable, we encourage you use the logs provided and to modify them to fit your needs.
Adverse Events and their documentation are very important for human subject protection as well as data integrity. An AE log serves as the collective source for adverse events that exist in multiple places e. AE logs must contain a description of each event, stop and start dates, action taken by the provider e. AEs on the log should have supporting source documentation with further detail.
View the AE Log. The concomitant medication log must contain the name of the medication, start and stop dates, and the reason the medication is being taken. The researcher must refer to the protocol to ensure that the subject is not taking medication that is prohibited from the protocol. You can download and add this template to your SharePoint Services, which enables you to create the following:.
The clinical trial template has site lists of libraries for clinical trial protocols, protocol documents, announcements, calendars, issues, tasks, and document discussions.
These can be further customized with different versions of SharePoint. To download this template, you will need access to SharePoint Server 3. In many instances, you set the clinical trial budget after much negotiation with a sponsor. The key cost drivers for any clinical research project are the following:.
Clinical research requires scrupulous planning, a well-developed team, regulatory adherence, and above all, excellent documentation. It is therefore critical for clinical trial project managers to have a completed scope of work and to develop all the forms and templates before the trial begins.
Some of these documents are for planning, and some, like those included below, are for operational purposes. Strong clinical practice thrives with a regulatory binder checklist. This checklist keeps track of all paper versions of essential regulatory study documents.
Each document should also include any electronic locations. This document should be regularly updated, customized for unique studies, and stored in reverse chronological order. It is important to not only track all paperwork related to a clinical trial, but also be able to locate it easily between various staff and sites.
A clinical trial document tracking log can help you keep a written trail of the documents and when they were submitted and approved. You should also keep copies of the documents with the log. Use this free template to develop your own clinical study document tracking log. You can also adapt the log for specific correspondence, such as documents relating to FDA or IRB submissions, but it should not be mixed with regulatory documentation.
Before you can undertake a study, you must develop a DSMP for how to keep participants safe and how to secure data and ensure accuracy. The DSMP has several sections:. Create your own data and safety monitoring plan using this free template. It lays out each section so you can specify them for your research.
The principal investigator should sign and date this document once it is complete so that it may be filed. A communication plan should describe how you will converse with internal and external stakeholders during your project.
Your communication plan should include a brief overview of your project and a breakdown of the messages you need to get out. You should adapt the messages for different audiences and define who will deliver these messages. The messages should include the following:.
Develop your own communication plan using this free clinical trial communication plan template. This template also includes a section for situation analysis and risk analysis that asks for inputs on strengths, weaknesses, opportunities, and threats. A few main documents help ensure that your participants are tracked and well-cared for before and during your research study.
This log keeps track of everyone that has been enrolled for participation in your study. This does not mean that they have met the eligibility requirements or have been otherwise screened, but it is a record that they have signed up to be admitted. Informed consent is the central tenet of ethical research with human subjects. Before you perform any research, make sure the informed consent document is signed and the participant receives a copy, unless the informed consent document has been waived by an institutional review board IRB.
Federal regulations 45 CFR These templates assist the principal investigator in the design of their informed consent forms ICFs. You can adapt them to accommodate the details of any study and include both the information sheet and the consent form. Modify each section with the appropriate description described in italics. Use the general template for any type of research. Eligibility criteria are an essential part of clinical trials.
They define the population under investigation. Inclusion criteria are the standards that participants must meet to enroll in the study. For example, in a study on a new diabetes medication, you would likely want participants who have already been diagnosed with diabetes.
Exclusion criteria specify the characteristics that disqualify participants from taking part in the research.
For example, in the diabetes study above, the proposed diabetes drug may target a specific age demographic. One exclusion criterion could be a participant whose age falls outside of the range. Properly documenting any medications that participants are taking is imperative to understanding the reactions occurring in their bodies, as well as what could spur adverse and severe adverse events during the study.
Fill out a concomitant medication log for every participant and account for everything participants take, even seemingly innocuous items like multivitamins. Clinical research can result in complications for the participants and trigger an adverse or severe adverse event. An adverse or severe adverse event is when participants in a clinical trial have negative medical symptoms that can be shown in laboratory or physical testing. Each participant in a clinical trial should have an adverse event log that tracks any adverse events through the duration of the study.
A severe adverse event SAE is a special case of an adverse event in which the outcomes are acute. Use multiple or master binders to maintain documentation if necessary. All Baystate Health System human subject research studies are subject to routine audits by the Human Research Protection Program and may also be reviewed by external entities such as the study sponsor or government agencies. Often sponsors will provide a regulatory binder. Federal Government.
Read our disclaimer for details. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits. Learn more. Try the modernized ClinicalTrials.
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