Month: December 2022

Learn what is A clinical trial protocol, why it’s important, what the protocol should include, and how to conduct a clinical trial with a CRO
This article will address the following topics:

1. What is a clinical trial protocol?
2. Why is a clinical trial protocol important?
3. What should a protocol for clinical trials include?
4. Conducting a clinical trial with a CRO
5. Clinical trials with Gsap

Clinical trials must strictly adhere to detailed protocols, which dictate every aspect of a trial. The clinical trial protocol documents the objectives, study design, methodology, statistical analyses, and general organization of a planned trial. It’s a critical document that helps to ensure that all data collected is robust, and also that the safety of trial participants is guaranteed. 

What is a clinical trial protocol?

A clinical trial protocol is a written document that forms the backbone of the clinical trial. The protocol is finalized before any clinical trial activities commence, and must be observed and adhered to throughout the trial.  A clinical trial protocol provides answers to many of the critical questions that come with a clinical trial, including: 

The clinical trial provides details for physicians, study coordinators, and other staff regarding how to execute the trial. It also describes timelines for the trial, as well as ensuring data integrity and patient safety. 

Before the trial commences, the protocol must be submitted for review by an ethics committee and be granted formal approval.

Why is a clinical trial protocol important?

A clinical trial simply can’t be completed without a clinical trial protocol. The protocol essentially acts as a set of quality control guidelines, put in place to protect both the participants in the trial and the integrity of data collected throughout the trial, and to ensure uniformity in the execution across all participating sites.

Specifically, a clinical trial protocol is important because: 

● It ensures the safety and health of all participants in the clinical trial 

● It details a strict and accurate study plan that all physicians, study investigators, coordinators, and trial staff must follow accordingly 

● It ensures consistency in data collection and integrity, meaning that data from multiple different study sites can be compared or compiled

● Approval from ethics committees for the conduct of clinical trial cannot be granted without a robust clinical trial protocol 

As you can see, the clinical trial protocol is crucial to the success of the trial itself. 

What should a protocol for clinical trials include? 

A clinical trial protocol needs to include all the information required to carry out the trial. More specifically, the protocol follows good clinical practice (GCP) guidelines or the closely related ISO 14155 guidelines for clinical trials of medical devices. GCP is an international ethical and scientific quality standard, which dictates how clinical trials should be conducted, and the roles of investigators, review boards, sponsors, monitors, and other stakeholders. 

So, now that we know what a clinical trial protocol is, here is an overview of what needs to be included in a clinical trial protocol:

Purpose of the clinical trial 

The clinical trial protocol must provide enough background information and rationale to outline the purpose of the trial, and justify why the trial is being conducted. The purpose of the trial will likely depend on the phase of the trial; earlier phase trials are usually to collect safety data, while later phase trials are to examine efficacy. 

Trial outcomes and measures 

The clinical trial protocol also needs to outline the measures that will define whether or not the trial is deemed successful. The protocol must detail measures that assess the safety and, if relevant, efficacy. Typically, a trial has one or two primary objectives and a few secondary or exploratory objectives. 

Study participant criteria

Any given clinical trial has a strict set of guidelines relating to who can and cannot participate in the trial. These inclusion and exclusion criteria depend (among other things) on the disease being studied and the treatment being evaluated. For example, participants in a trial drug efficacy trial will likely need to have the condition or disease that the drug is being evaluated for. Exclusion criteria that could prevent a patient from participating in a trial may include age, medical history, or other medications that the patient is currently taking. 

Study design and details 

Other elements that need to be included in a protocol for a clinical trial include: 

● The length of the trial and the number of participants needed 

● The schedule relating to the frequency and duration of clinical visits for participants 

● Suitable control measures, and whether or not some participants will be issued a placebo

To summarize, a clinical trial protocol must satisfy GCP guidelines, therefore ensuring both the integrity of the trial and the safety and well-being of trial participants. 

Conducting a clinical trial with a CRO

As shown above, a clinical trial protocol needs to be extremely thorough and provide all necessary information to satisfy GCP guidelines and ethical considerations. If a clinical trial protocol is incomplete or insufficient, the trial will likely not receive ethics approval, and therefore cannot proceed. In addition, the trial objective must be carefully considered for the trial to meet the target and succeed.

Given that the clinical trial protocol is such a critical component of the trial itself, and essentially dictates how the trial will proceed, it is often necessary to enlist the services of a professional clinical research organization (CRO). A CRO works closely with the study sponsor to ensure that the clinical trial protocol contains all the necessary details for the trial to be approved. 

CROs offer medical writers, clinical experts, and regulatory specialists that can assist in the clinical design and protocol development of your trial. 

Clinical trials with Gsap

Gsap is a full-service CRO with years of experience in the design and execution of clinical trials. Gsap offers a team of professionals that can work with you to develop the clinical trial protocol, along with providing any other support your trial needs. 

A boutique CRO providing personalized support

As a boutique CRO, Gsap ensures that you have more than an organization to develop your clinical trial protocol and manage your trial – you have a partner to assist you every step of the way. 

Gsap has helped many clients create clinical trial protocols and manage the transition from pre-clinical development to clinical studies. The Gsap holistic approach to CRO services helps to ensure the success of your own clinical trial. 

Contact Gsap today to discuss your upcoming clinical trial. 

This article was prepared by:

Matti Hoggeg, M.Sc.

Clinical Section Manager

For more information about our CRO services visit:

In this article, we will discuss clinical trial monitoring in great detail, including what it is, what processes are involved, and why it is essential for the success of any clinical trial.

We will address:

1. What is Clinical Trial Monitoring?
2. The Importance of Clinical Trial Monitoring
3. The Purpose of Clinical Trial Monitoring
4. The Three Types of Clinical Trial Monitoring
5. The Services of Clinical Trial Monitoring
6. Clinical Trial Monitoring with Gsap

What is Clinical Trial Monitoring?

Clinical trial monitoring refers to the process of overseeing the progression of a clinical trial. Monitoring in clinical trials involves supervising consent documentation, protocol compliance and adherence, data collection and review, safety data collection and reporting, and much more. 

The Importance of Clinical Trial Monitoring

The importance of clinical trial monitoring cannot be overstated. Rigorous monitoring is essential for several reasons, including: To ensure that human subjects are treated ethically and their well-being is protected

● To ensure that all data collection is consistent and accurate, particularly across multiple trial sites

● To ensure that all reported data is complete, accurate, and verifiable, with source documentation 

● To ensure that the trial is carried out according to the outlined and approved study protocols and SOPs

Clinical trial monitoring is critical to ensure that accurate, reliable data is collected in an ethical manner throughout the trial process.

The Purpose of Clinical Trial Monitoring

The primary purpose of clinical trial monitoring is to scrutinize and verify the quality of the trial at every stage. Monitoring ensures that a trial is conducted according to the study protocol, with all necessary recording and reporting following the relevant standard operating procedures (SOPs), as well as regulatory requirements and Good Clinical Practices (GCPs). 

The Three Types of Clinical Trial Monitoring 

Clinical trial monitoring falls into three broad categories.

These include:

On-site

On-site clinical trial monitoring requires in-person assessment, carried out by clinical staff or sponsor personnel, at the trial site. On-site monitoring is the traditional form of clinical trial monitoring and was the most common form of clinical trial monitoring prior to the COVID-19 pandemic. 

Remote

Remote monitoring in clinical trials has become more accepted in recent years. Unlike on-site monitoring, monitors do not visit trial sites during remote monitoring in clinical trials. Instead, data review and transfer are done using secure, specially-designed digital platforms. 

Centralized

Centralized monitoring in clinical trials is the most appropriate option when there are multiple trial sites. Centralized monitoring arose due to the publication of guidelines relating to risk-based monitoring (RBM), and involves the collation of data from all trial sites to a central location for real-time evaluation. 

The Services of Clinical Trial Monitoring

As mentioned, monitoring clinical trial processes involves a diverse number of services. These are some of the key elements of clinical trial monitoring:

Protocol compliance and protocol deviations

Strict adherence to study protocols and SOPs is essential in any clinical trial. The study protocol is written, reviewed, and approved prior to the commencement of the study, and any changes to the protocol, or deviations from the protocol, need to be appropriately documented throughout the trial. 

Data collection and missing data

Another clinical trial monitoring service is the oversight of data collection. Clinical trial data must be accurate, complete, and verifiable from source documentation. It’s the role of a clinical trial monitor to ensure that this is the case. In addition, the collection of participant data needs to be performed according to the relevant data protection and privacy laws/guidelines. 

ICF and Consent Process Review 

Informed consent forms (ICFs) are a critical component of patient enrolment. Part of the process of clinical trial monitoring is to oversee patient enrolment and ensure that informed consent from each subject is appropriately obtained and documented. 

Source data review (SDR) vs source data verification (SDV)

SDR and SDV are important elements of risk-based quality management. SDV refers to the process of confirming that reported analytical data accurately reflects the source data collected at the trial site, primarily on the case report form (CRF). 

On the other hand, SDR refers to the review of source documents as they related to the clinical trial protocol. Compared to SDV, SDR involves a more strategic approach that focuses intently on the quality of data collection and compliance with regard to the study protocol. 

IP/device compliance

An investigational product (IP) is a drug or biological product being used in a clinical trial, while an investigational medical device is typically a physical object (such as a pacemaker). Regardless of whether a trial is assessing a product or a device, compliance is integral to the trial’s success. A clinical trial monitor is responsible for ensuring compliance when it comes to how the investigational product or device is used in relation to the study protocol. 

Safety data collection, review, and reporting 

Safety data is one of the most important pieces of information gleaned from the study. Many trials are conducted solely to determine the safety of a potential new drug or device. During the study conduct safety data is collected and reviewed on an ongoing basis in order to ensure subject safety and safe flow of information.

Documentation review and collection 

Clinical trial monitoring also involves the collection and review of the numerous documents associated with clinical trials. This process may include a review of CRFs, ICFs, and other source documentation such as hospital records and laboratory notes, and the collection of essential documents required to be part of the Trial Master File (TMF), which is the main repository of trial documentation. A critical component of document review is ensuring that all documentation is complete, legible, accurate, version controlled, and contemporaneous. 

Equipment, ancillary supply, and logistics 

All equipment being used in a clinical trial such as thermometers, centrifuges, etc. must be appropriately calibrated and validated, with associated documentation such as SOPs, logbooks, and training forms. Clinical trials also require a large number of ancillary supplies such as diagnostic and testing materials, and more. All equipment and materials used in or associated with clinical trials must be GCP grade, stored, and used appropriately. Coordinating this is a critical part of clinical trial monitoring. 

Clinical Trial Monitoring with Gsap

Without adequate clinical trial monitoring, significant time and money may be wasted on a trial that does not meet the necessary quality standards for successful submission or review. An experienced and trusted contract research organization (CRO) can ensure that all elements of your trial run smoothly. 

Gsap is a boutique CRO with vast experience across a wide range of clinical trial therapeutic areas and phases including cell therapy, gene therapy, cannabis, MD, and DH. Contact Gsap to discuss your upcoming clinical trial. 

This article was prepared by:

Matti Hoggeg, M.Sc.

Clinical Section Manager

For more information about our CRO services visit: