Study design in OC is a protocol preparation process for study. This includes:
- Establishment of a Study Record
- Establishing Patient Attitudes or Placeholders
- Establishing Events or Study Visits
- Appointment of sites or sites where the data are collected
- You must create a chart of required objects, sites, and investigators before you complete the design process.
It is advisable to review all protocol and study documents prior to the establishment of the study to ensure that you have all the necessary information, but you can always change the design elements at any time except the name of the study.
Once the design of the study has been completed, you can go to the following module: Definition of the study (creation of CRFs) and development of procedures (edit checks and derivations).
- New studies records are created in the Easy Design Unit (Design, Studies and Easy Design)
- Make sure there are planning objects required for the study
- in an easy design model of study creation. Enter the name or number of the study, issue it and describe the study / title. Some parameters are optional. Once you click Save, the system will prompt you to choose whether the study requires 2 Pass data.
- Program: Code (name) of the compound under investigation
- Protocol: A document describing the plan of action for the study of the study
- 19659003] Project: Code (name) of the reference under investigation
- Study: Name of the clinical study
- Organizational unit: Code (name) of the unit responsible for the study  Event: Name] of the site in which the study is conducted
- Patient Attitudes: ID of the participant in the study
- Location: A site where all or part of the study was conducted
• The study schedule is used to determine when the data is collected or to track the purposes (lost or delayed DCMs)
consists of One or more periods of one or more events (time)
• The schedule consists of interviews that are divided into events. By default, each study is pre-populated with two default hypotheses that can be used to create events.
• To create puzzles, select the study in the Easy Design module and click on the intervals. Periods are defined by phase name, short name, stage type, blind type (single, double, etc.) and minimum and maximum duration. The period is used to calculate when the period is expected to occur within the study.
• To create events, select the study in the Easy Design module and click Events. Create all the events (visits) during which data will be collected during study. Events are determined by event name, interval, visit number (command expected), minimum and maximum offset from start of interval.
• Time calculations (juvenile compensation and interval intervals) are useful only for descriptive purposes and to determine whether CRF numbers are missing or delayed.
If this function is not required, this information is not useful in the implementation of the study.
Study Design – Patient Attitudes
• Patient attitudes are the constituents of the actual participant in the study. For each patient, each patient should have a unique patient status in this study.
• It can be bonded in blocks or one by one.
• Patients can be of several types: screening, normal or replacement.
For normal patients, use NORMAL.
The substitution is used in random distribution.
• To create patient conditions, select the study in the Easy Design module; click Create PP. Create the patient's site to study by entering the start and end numbers.
• Duplicate numbers are not allowed in the study.
Study Design – Sites and Investigators
• Sites are sites where data is collected and researchers are represented by a medical researcher in charge of the site. It can be used in multiple studies.
• Each study requires at least one dedicated site with an investigator dedicated to this site.
• Create sites in the Sites module. The site is defined by code, name, phone number, address, city, state, country, and zip code. Site code must be unique.
Design -> Detectives and Sites -> Sites
Create investigators in detective unit. The investigator is identified by an investigator code, last name, last name, and phone number. Optional. The investigator code must be unique.
Design -> Investigators and Sites -> Investigators
• Assign an investigator to each site. There can only be one active investigator dedicated to a site at any time. If a second investigator is assigned to the same site, the system automatically enters the "end date" for the current investigator.
• Appointment of patients' positions to study sites. Patients may be enrolled optionally in the study. Patient registration can be performed in the registration unit.
Tip: The system only requires a registration date to consider the patient's condition "under registration". However, the laboratory scope system will not work without entering the patient's date of birth and gender.