FAQ

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.

https://ccts.osu.edu/content/regulatory-documents 

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.

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.

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.

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.

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. 

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 

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).   

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.  

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.  

You must use ClinicalTrials.gov to fulfill the requirements of FDAAA 801 (PDF). FDAAA 801 requires Responsible Parties to submit clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov. 

Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.