Regulatory Affairs

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  • What are essential regulatory documents?

    ICH GCP guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. In addition, these documents serve to demonstrate the compliance of the investigator, Sponsor, and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.


  • What is ICH E6 Good Clinical Practice (GCP)?

    Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects

  • What is an eTMF?

    An eTMF is an electronic file containing the essential documents for a clinical trial to record how the Sponsor fulfilled their obligations for the trial. The electronic process of compiling documents records how the clinical trial is conducted and all regulatory requirements are fulfilled. The TMF is set up at the beginning of the trial, it allows clinical monitors, auditors, and other study team members to access documents and perform effective oversight of the trial.

  • Who is responsible for the eTMF maintenance and accuracy?

    The Sponsor is responsible for the TMF and must ensure that the TMF includes all essential documents, is securely stored, and has limited and restricted access. CRMSO can offer TMF development and management support throughout the study.

Project Management

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  • What does a CRMSO clinical research project manager do for your study?

    A CRMSO project manager is responsible for managing the clinical project to achieve the objectives of a study following a high-quality standard-driven process. At CRMSO the project manager will serve as a liaison for all stakeholders involved in the study lifecycle. The clinical research project manager from CRMSO will facilitate that all the clinical trial stages are properly managed, completing the main objectives on time, on budget, and according to the GCP guidelines.

  • What are the advantages of having a project manager from CRMSO?

    Having a project manager from CRMSO supporting your trial will facilitate maintaining the processes and quality standards you want to achieve. In addition, the project manager will strive to help you meet the objectives of your study. CMRSO project managers help to reduce wasted effort, assist with the tracking of progress (or lack of it), and quickly intervene and respond in case there are deviations from important goals in a project.

  • How will I interact with my assigned Project manager?

    The CRMSO Project manager will communicate often with the study PI and their respective team, as well as all stakeholders for the project. A communication plan is developed to document the communication and escalation process.

    Short and productive project follow-up meetings are established and held bi-weekly until study activation, monthly until all sites are activated, and quarterly thereafter.

  • What type of reports can I expect from the Project Manager of my study?

    Study reports will include but are not limited to site status, enrollment rate, and key performance indicators such as data entry status, aging of open queries, as well as adverse events, and protocol deviations.

Site Management

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  • What does a clinical research monitor do?

    Clinical Research Monitors make sure that the research data is collected and recorded as per the protocol. Monitors periodically review study records, to confirm adverse events and other relevant study data are recorded as per the protocol guidelines and in compliance with Federal regulations and GCP. In addition to reviewing study data, monitors help in site activation and the closeout process once the study has been completed.

  • How does CRMSO develop a monitoring plan?

    The monitoring plan differs for each study. The level of monitoring depends on the risk involved, patient population, and complexity of the trial. At CRMSO a risk analysis is completed, and thereafter the monitoring plan is developed. The frequency of monitoring depends on the risk factors associated with the study.

  • What are the different types of clinical monitoring?

    The monitoring plan at CRMSO is designed based on the risk analysis for each study.  

    There are three main types of monitoring- on-site, remote, and centralized.  

    On-Site Monitoring: This involves in-person evaluation of the study, the monitor goes to each participating site and reviews all patient data, pharmacy (drug accountability), and other facilities involved in conducting the research. 

    Remote Monitoring: In this type of monitoring, the participating site provides remote access to the monitor to their patient records, regulatory files, pharmacy logs, temperature logs, etc., to make sure the study is conducted in accordance with the GCP guidelines and follows the study protocol.  

    Centralized Monitoring: This is a statistical approach, consisting of a remote evaluation carried out by a monitor at a location other than the participating site at which the study is being conducted.  







  • What types of monitoring visits will occur during my study?

    Typically, you can expect different types of monitoring visits to occur for your study. In general, these will be the Pre-Study Visit (PSV), Site Initiation Visit (SIV), Routine Monitoring Visit (RMV), and Close-Out Visit (COV). Central Monitoring is conducted at a specified time according to the monitoring plan.

  • What occurs at each type of monitoring visit?

    Each monitoring visit type occurs at specific timepoints during the study  

    Pre-Study Visit (PSV): The Pre-Study Visit, sometimes referred to as the Site Selection Visit or Pre-Study Qualification Visit is the first visit that occurs at a site/institution. The purpose of this visit is to ensure the site and research personnel have the necessary qualifications/credentials, experience, facilities/equipment, etc. to conduct a study. The visit also serves to assess if the site has the targeted patient population to be able to meet recruitment expectations.  

    Other topics addressed during this type of visit are typically a high-level overview of the protocol (protocol synopsis), systems/portals to be used during the study, a review of the investigational drug or device, and non-standard of care assessments, etc.  

    Site Initiation Visit (SIV): The Site Initiation Visit occurs before any patient recruitment/enrollment and serves to assess whether the site is ready for activation, or ready to begin the study. The purpose of the visit is to ensure site personnel are trained on the protocol and prepared to consent patients into the study.  

    The following topics are typically reviewed during the SIV: 

    • Background and purpose of the study, including study objectives and style 
    •  Procedures of the study 
    •  Investigator’s Brochure (IB) or Device Investigational Plan (device description section), or reference product label. 
    • Investigational product(s): Pharmacological or technical aspects of the product(s), management, and accountability utilizing an investigational product accountability log 
    • Recruitment of subject and screening, including criteria for inclusion and exclusion 
    • Obtaining consent 
    • All essential documents such as report forms (CRFs), consent forms, etc. 
    • Monitoring expectations 
    • Adverse Event/Adverse Device Effect Reporting 
    • Data collection and record-keeping 

    Routine Monitoring Visit (RMV): Routine Monitoring Visits, sometimes referred to as Interim Monitoring Visits (IMVs), are conducted at a frequency outlined in the monitoring plan. This type of visit is the first visit after the first enrollment and occurs periodically throughout the study to ensure compliance, subject safety, and audit readiness.  

    Close-Out Visit (COV): The Close-Out Visit occurs after the last subject at the site has completed the study, all data has been collected, and the database is locked and prepared for statistical analysis. Close-out activities ensure that the studying procedure, all regulatory documents, and data are 100% completed, and any Investigational Product (IP) or supplies are returned or destroyed with documentation of the details pertaining to the destruction. The Principal Investigator (PI) must be available to sign off all the documents required for the closeout to be completed. 

    The purpose of the Close-Out Visit is to make sure that everything is neat at the study site which means the documentation is well organized and is accessible in the future as required for regulatory reasons. 

  • How can my site prepare for a monitoring visit?

    The best way to prepare for a monitoring visit is to refer to the previous visit’s follow-up letter. Within the follow-up letter, your monitor will document any action items including missing or expired regulatory documents, required training documentation, open queries, missing data, discrepancies in source, protocol deviations, etc.  

    Additional actions to take that can help prepare your site for an upcoming monitoring visit include: 

    • Complete all necessary CRFs 
    • Confirm that Serious Adverse Event (SAE) forms have been submitted and are available for review 
    • Obtain medical records for the CRFs to be reviewed 
    • Organize study file documents for review 
    • Confirm that signed consent forms for all enrolled participants are available 

Data Management

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  • What is the goal of data management in the clinical trial process?

    The goal of data management is very simple. Data managers work to produce high-quality, reliable, and statistically analyzable, data for clinical trials (Krishnankutty, Shantala, Naveen & Moodahadu, 2012).   

  • What does a CRMSO data manager do?

    A specific data manager within CRMSO is assigned to a study project. Each data manager will design each aspect of the study database and its supporting documents for their project. They will monitor that the data is collected and processed and that the integrity of the data is maintained throughout the trial. The data manager will also facilitate data adherence to the  FDA and other regulating guidelines 

  • What are the advantages of having a CRMSO data manager on your team?

    A CRMSO data manager brings another type of perspective to the study team. They concentrate on placing processes and procedures that follow good data management practices. Their emphasis is to ensure that the integrity of the data is maintained and quality is upheld. They work to ensure that this occurs during the course of the study project.  

Clinical Trial Disclosure

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