Clinical Trials

 

 

 

	Investigator’s Brochure (IB) The Investigator’s Brochure (IB) is a comprehensive compilation of clinical and non-clinical data relevant to investigational products being studied in human subjects. Its primary purpose is to assist investigators and other trial personnel in understanding and adhering to critical aspects of the study protocol—such as treatment dose, dosing frequency, administration methods, and safety monitoring procedures. Additionally, the IB provides valuable information to support the clinical management of trial participants.   The Investigator’s Brochure (IB) typically contains:          A title page          Table of contents          Summary          Introduction          Description of IP physical, chemical and pharmaceutical properties and formulations          Summaries of non-clinical studies          A description of effects in humans          A summary of data and guidance for Investigator.
	Summary of Product Characteristics (SPC or SMPC) A Summary of Product Characteristics (SPC) is a monograph for medicines created and regularly updated by pharmaceutical companies based on their research and product knowledge. It provides essential information about a medicine’s form, clinical parameters, and pharmacological properties.   The SPC explains how to use and prescribe the medicine and is primarily intended for healthcare professionals such as doctors, nurses, and pharmacists.
	Informed Consent Form (ICF) Informed Consent Document (ICD) or Informed Consent Form (ICF) is a document containing important information about a medical procedure or treatment, a clinical trial, or genetic testing. It also includes information on possible risks and benefits. If a person chooses to take part in the treatment, procedure, trial, or testing, he or she signs the form to give official consent.   The informed consent process involves three key features:          Disclosing to potential research subjects information needed to make an informed decision;          Facilitating the understanding of what has been disclosed          Promoting the voluntariness of the decision about whether or not to participate in the research.
	Clinical Study Protocol (CSP) A Clinical Study Protocol (CSP), sometimes also referred to as Clinical Trial Protocol or simply as Protocol, is an overview of how the study will be executed, it contains a description of the study objective(s), design, methodology, statistical considerations, and organization of the study.   Well-written CSPs are essential to the conduct of successful clinical studies. Clinical studies frequently falter because they try to do too much, and their design and intent is poorly communicated in their study protocols.   Protocol Elements:            Table of Contents          Introduction/Abstract          Hypothesis          Objectives and Rationale          Methods and Procedures          Subject Population Selection and Inclusion/Exclusion Criteria          Risks and Benefits          Provisions for Treatment of Adverse Events          Subject Recruitment          Review Preparatory to Research and Recruitment          Subject Compensation/Reimbursement          Study Management and Personnel          Confidentiality and Data Storage          Data Analysis and Evaluation Techniques          Bibliography          Appendices.
	Case Report Form (CRF) A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting.   All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions.   Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
	Clinical trials liability insurance Even the most well prepared, perfectly executed study can have serious consequences.   Clinical trial insurance helps protect the sponsoring company from financial liability by covering costs such as legal expenses and medical expense compensation for the affected participants.
	Statistical Analysis Plan (SAP) The statistical analysis plan (SAP) describes the intended clinical trial analysis. The SAP is a technical document that details the statistical methods of research analysis, as opposed to the protocol, which represents the analysis.
	Study results Study Results means all data, information, test results, laboratory notes, techniques, know-how and any other scientific and technical information obtained in the performance of the Studies by any Study Member. The study's data should be presented in a logical sequence without bias or interpretation. Findings may be reported in written text, tables, graphs, and other illustrations.
	Adverse Event/Serious Adverse Event Adverse Event – any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Where to find Adverse Events:          Physician and nurse notes in source documents          Diaries completed by the subject          Assessment forms and questionnaires          Indications for concomitant medications          Abnormal laboratory data          CT scan, MRI, radiology reports          Reasons for withdrawals and drop-outs          Reasons for missed visits.   Serious Adverse Event – this is any untoward medical occurrence that:            Results in death          Is life threating          Requires inpatient hospitalization or prolongation of existing hospitalization          Results in persistent or significant disability/incapacity          Results in a congenital anomaly/birth defect; OR          Is considered to be an important medical event requiring intervention to prevent any of the above.
	Site monitoring visit report Monitoring Report – a written report from the Monitor to the sponsor after each site visit and/or other trial- related communication prepared according to the sponsor's SOP.   The purpose of clinical site monitoring is to ensure that the rights and well-being of the study participants are protected, the quality and integrity of the data are maintained, and all study files and conduct of trial comply with the currently approved protocol, GCP, and all applicable regulatory requirements.
	Product description Product descriptions are marketing copies used to provide details and information about a product being sold. The writing should encourage shoppers to add the item to their cart. Descriptions are typically on product detail pages. They can be one to two sentences long, or be in bullet form. Product descriptions help a customer make informed purchasing decisions. They also make your website look professional, as it would be absurd to just list products and their prices, without informing the customer about them.
	Patient Diary/Event Log A patient diary can be used to capture everything a patient experiences during their treatment, post treatment, and how they feel outside and inside of a hospital setting. There are variations of a patient diary that target specific areas of the patient experience.   In clinical trial a patient diary is a tool to assess the patient's condition (e.g. symptom severity, quality of life) or to measure treatment compliance.