Clinical Research Online Course
Feasibility assessment is a critical step in conducting a successful clinical trial. Selecting the right site can be beneficial for both the sponsor and the clinical site. In addition, it can provide an opportunity for many patients to be enrolled in a study that may change their life. Therefore, the…
A Note to File (NTF) is a record that allows the clinical site and the sponsor to document an identified issue or discrepancy during a clinical study. A NTF should include the following items: · The root cause of the discrepancy/issue · The corrective action taken to prevent its recurrence · Explanation of…
The Informed Consent Form (ICF) is one of the documents that is reviewed by the CRA during the monitoring visit. It is the CRA responsibility to ensure that the patient (subject) has been consented, appropriately. If the consent is not signed or completed properly, additional training for the Clinical Research…
Clinical Research Associates (CRAs) have several responsibilities. Source Data Review (SDR) and Source Data Verification (SDV) are the most common tasks that CRAs perform during a monitoring visit. SDV is basically conducted to compare Case Report Form (CRF) to source data. SDR is a review of source documentation to check quality…
Several clinical trials require specific lab tests. Depending on the study protocol the lab tests are required to establish inclusion and exclusion criteria, monitor the safety of the patients enrolled in the study or demonstrate the efficacy of the investigational product (IP). The sponsor/CRO has two options for gathering clinical…
A clinical study protocol is a document that indicates how the clinical trial is going to be conducted. Clinical Project Managers and Clinical Research Associates (CRAs) usually work on one study/protocol at a time. They also need to train clinical sites and answer questions from PI or study staff; so,…
If you are planning to enter clinical research field and you don’t have experience working with the software used in this area you don’t need to be worry. Remember the first time you had to start working with a new software, how did you learn about it? training? watching videos on Youtube?…
If you are thinking of becoming a Clinical Research Coordinator or have an interview coming up for this role; here are 5 important transferable skills, you need to consider. Verbal Communications One of the most important skills you need to have for this position is to be able to communicate…