Documents Needed For Clinical Trials

Note: Want to skip the guide and go straight to the free templates? No problem - scroll to the bottom.
Also note: This is not legal advice.

Introduction

Clinical trials are an essential part of the medical research process, enabling the development of new treatments and cures for diseases. The aim of these trials is to evaluate the safety and effectiveness of medications, treatments, and medical devices when tested on humans. These are closely monitored by regulatory bodies such as the FDA who divide clinical trials into three phases – firstly assessing a small group of people to see if treatments are safe and effective, then a larger group before finally testing it on even more people.

It is crucial that clinical trials are conducted ethically, taking into account the safety of all participants whilst weighing up potential risks against any benefits. All involved must consent to take part in the trial too - which is where Genie AI comes in. Founded in 2017, Genie AI is a pioneering open source legal template library used by millions worldwide to draft high quality documents without paying lawyers; it’s designed specifically with ethical considerations in mind. This community template library offers guidance on what constitutes acceptable consensus with regards to clinical trials so everyone can benefit from accurate data collection and reporting - ensuring information remains confidential throughout.

In offering this free service Genie AI wants anyone conducting clinical trial research to feel confident they have taken every step necessary to gain informed consent from participants while understanding that taking part does not require a Genie AI account. So if you’re looking for step-by-step guidance or need access our comprehensive legal template library today – make sure you read on!

Definitions (feel free to skip)

Interventional Trials: Clinical trials in which new treatments or interventions are tested.
Observational Trials: Clinical trials in which outcomes are recorded without intervening.
Diagnostic Trials: Clinical trials in which new diagnostic tools or methods are tested.
Pharmacogenomic Trials: Clinical trials in which the effect of drug therapies on specific genetic populations is tested.
Regulations and Guidelines: Official rules and standards that must be followed in order to ensure legal compliance.
Protocol Document: A document that outlines the objectives, methodology, timeline, and other details of a clinical trial.
Informed Consent Document: A document that outlines the risks, benefits, and other details of a clinical trial.
Monitoring Plan: A document that outlines the processes and procedures that will be used to monitor and audit a clinical trial.
Sponsor: The individual or organization responsible for the overall direction of a clinical trial.
Investigator: The individual responsible for the implementation of a clinical trial.
Clinical Research Coordinator: The individual responsible for the day-to-day management of a clinical trial.
Risk Assessment: An analysis of potential risks that may arise during a clinical trial.
Contingency Plan: A backup plan in case of a delay or unforeseen circumstances.

Contents

• Overview of the Clinical Trial Process
• Understanding the clinical trial process and timeline
• Identifying the types of clinical trials
• Regulatory Requirements for Clinical Trials
• Understanding the regulatory requirements for different countries
• Applying for clinical trial authorization and registration
• Obtaining Ethics Approval for Clinical Trials
• Preparing the necessary documents for ethics approval
• Submitting the documents for review
• Following up on the ethics approval process
• Required Documentation for Clinical Trials
• Creating a protocol document
• Developing an informed consent document
• Creating a monitoring plan
• Roles and Responsibilities of Clinical Trial Participants
• Understanding the roles of the sponsor, investigator, and clinical research coordinator
• Outlining the responsibilities of each participant
• Collecting and Reporting Data for Clinical Trials
• Setting up a system to collect and store data
• Establishing processes to ensure accuracy of data
• Reporting the data according to the protocol
• Monitoring and Auditing Clinical Trials
• Setting up a system to monitor adherence to protocol
• Ensuring protocol compliance and accuracy of data
• Performing regular audits to identify and address issues
• Guidelines for Closing Clinical Trials
• Generating a final report
• Verifying that all data points have been recorded
• Ensuring all participants have completed the trial
• Potential Challenges and Solutions for Clinical Trials
• Identifying potential challenges
• Developing strategies to mitigate risk
• Developing contingency plans for unexpected events
• Dissemination of Results
• Publishing results in peer-reviewed journals
• Presenting findings at conferences
• Sharing results with relevant stakeholders

Get started

Overview of the Clinical Trial Process

• Understand the different phases of clinical trials and the possible risks/benefits associated with each phase
• Recognize the different players involved in the clinical trial process, such as the sponsor, investigator, and regulatory agencies
• Learn the different documents required for a clinical trial and the roles they play
• Understand the process for obtaining consent from participants
• Understand the regulatory requirements for the clinical trial process
• Be aware of the timelines and deadlines associated with the clinical trial process

Once you have an understanding of the clinical trial process and the documents needed, you can check this step off your list and move on to the next step.

Understanding the clinical trial process and timeline

• Learn about the types of clinical trials available to you
• Understand the timeline for the clinical trial process
• Learn about the different stages of the clinical trial process
• Understand the different roles and responsibilities of the clinical trial team
• Get a clear understanding of the documents needed for the clinical trial process
• Determine the time frame for the clinical trial
• Once you understand the clinical trial process and timeline, you can move on to the next step.

Identifying the types of clinical trials

• Research the types of clinical trials available, such as interventional, observational, and diagnostic trials
• Understand the difference between a Phase I, Phase II, Phase III and Phase IV trial
• Ascertain the eligibility criteria for each type of trial
• Assess the potential risks and benefits of each type of trial
• Determine which type of clinical trial is right for your research
• When you have identified the type of clinical trial you want to pursue, you can then move on to the next step in the process: the regulatory requirements for clinical trials.

Regulatory Requirements for Clinical Trials

• Research the local regulatory requirements for each country that the trial will occur in
• Obtain the necessary licenses and approvals in each country
• Ensure that all protocols comply with local regulations in each country
• Make sure that all documentation is in accordance with the regulations of each country
• Make sure to keep up-to-date with any changes to the regulatory requirements for each country
• When all necessary licenses and approvals have been obtained, and all protocols and documentation are in compliance with the local regulations, you can check this off your list and move on to the next step.

Understanding the regulatory requirements for different countries

• Determine the regulatory requirements for each country you plan to conduct the clinical trial in
• Find out which documents are necessary to apply for clinical trial authorization and registration in each country
• Understand the timelines and fees associated with the authorization and registration process for each country
• Gather the necessary documents and ensure they meet the requirements of each respective country
• When you have all the documents needed, you are ready to move on to the next step: Applying for clinical trial authorization and registration.

Applying for clinical trial authorization and registration

• Determine the applicable regulatory requirements for the country you are conducting the clinical trial in.
• Gather all necessary documents for the clinical trial authorization and registration application.
• File the application with the relevant authority, along with the necessary documents.
• Follow the process from the authority for the clinical trial authorization and registration, including submitting any additional documents that may be requested.
• Wait for the authorization and registration to be granted.
• You will know you can check this off your list and move on to the next step once your clinical trial authorization and registration has been approved.

Obtaining Ethics Approval for Clinical Trials

• Check with local regulatory authority for the requirements needed for clinical trial authorization and registration
• Make sure all the necessary documents for ethics approval are prepared and submitted for review
• Respond to any questions the regulator may have about the trial
• Once you receive approval from the regulator, you can proceed to the next step in the process

Preparing the necessary documents for ethics approval

• Gather all the relevant clinical trial documents, such as the protocol, Investigator’s Brochure (IB), informed consent document (ICD), and any other relevant documents
• Ensure all the documents are up-to-date and meet the standards of the relevant regulatory bodies
• Prepare a cover letter to submit along with the documents, explaining the purpose of the trial and the regulations that have been adhered to
• Once the documents are ready, you can check off this step and move on to submitting the documents for review.

Submitting the documents for review

• Submit all the necessary documents to the ethics committee for review.
• Ensure that all the documents have been fully completed and signed.
• Contact the ethics committee to confirm that the documents have been received.
• Wait for the ethics committee to review the documents and provide feedback, if any.
• Once the documents are reviewed and approved by the ethics committee, you can check this step off your list and move on to the next step.

Following up on the ethics approval process

• Contact the ethics committee or review board to check the status of the application
• Track the progress of the ethics submission and make sure all documents are in order
• Follow-up with the ethics committee or review board to address any queries or changes required
• Once the ethics committee or review board has given the green light, you have successfully completed the ethics approval process
• Move on to the next step of the clinical trials guide: Required Documentation for Clinical Trials.

Required Documentation for Clinical Trials

• Gather all relevant documents related to the clinical trial, such as informed consent forms, investigator’s brochures, and the study protocol
• Ensure that all documents have the required approval from the relevant authorities
• Compile the documents into a binder to create a document package
• Submit the document package to the review board for approval
• Once approved, you can move on to the next step in the process

Creating a protocol document

• Research existing protocols related to the trial and make sure they are relevant
• Outline the purpose, design, methodology, and expected outcomes of the trial
• Identify the resources needed for the trial, including personnel, funding, and equipment
• Define the roles for all personnel involved in the trial
• Specify the criteria for eligibility of trial participants
• Outline the methods for data collection, analysis, and reporting
• Determine the timeline for the trial, including the start and end dates
• When complete, review protocol document with internal and external stakeholders
• When approved, the protocol document is ready to be used for the trial
• Check off this step when the protocol document is approved and ready to be used for the trial.

Developing an informed consent document

• Consult with a legal professional to ensure the document meets all regulations
• Gather information to include in the document, such as the risk and benefits of participating in the trial, how confidentiality will be maintained, how the data will be used, and how to withdraw from the trial
• Design the document with a clear, concise format that is easy to understand
• Seek feedback on the document from potential trial participants
• Make revisions as needed
• Once the document meets all regulations, is clear and concise, and has been approved by potential trial participants, it is ready for use
• Check off this step from your list and move on to the next step of creating a monitoring plan.

Creating a monitoring plan

• Establish a system for collecting and reviewing data from all sites involved in the clinical trial
• Create a monitoring plan that outlines your approach for collecting and assessing data
• Identify the personnel responsible for conducting the monitoring and their roles
• Identify the personnel responsible for responding to any issues that arise during the monitoring and their roles
• Ensure the monitoring plan is compliant with all applicable regulations and standards
• Once the monitoring plan is established and approved, it can be checked off the list and the next step can be completed.

Roles and Responsibilities of Clinical Trial Participants

• Identify the roles and responsibilities of the clinical trial participants (e.g. the investigator, sponsor, clinical research coordinator, etc.).
• Establish communication between all clinical trial participants and ensure they are aware of their respective roles and responsibilities.
• Familiarize yourself with the regulations and guidelines related to clinical trials, such as the ICH-GCP and the FDA’s regulations.
• Create a document outlining the roles and responsibilities of each clinical trial participant.
• Ensure that all clinical trial participants are aware of the document and follow the outlined roles and responsibilities.

When you can check this off your list and move on to the next step:

• When you have identified the roles and responsibilities of the clinical trial participants.
• When you have established communication between all clinical trial participants and ensured they are aware of their respective roles and responsibilities.
• When you have created a document outlining the roles and responsibilities of each participant and all participants have acknowledged the document.

Understanding the roles of the sponsor, investigator, and clinical research coordinator

• Understand the roles and responsibilities of each participant in the clinical trial: Sponsor, Investigator, and Clinical Research Coordinator.
• Learn about the regulations and requirements for sponsors, investigators, and clinical research coordinators, such as qualifications and training.
• Make sure that you have the appropriate documents and paperwork to be able to begin the clinical trial.
• Ensure that you are familiar with the regulations, policies, and procedures that may affect the conduct of the clinical trial.
• When you have all of the required documents, you can check off this step and move on to the next step.

Outlining the responsibilities of each participant

• Ask the sponsor and investigator to provide a clear written description of roles, responsibilities, and requirements for each participant.
• Ask each participant to review and sign a document that outlines their responsibilities and any associated risks.
• Have each participant review and sign an informed consent document.
• Make sure each participant fully understands their duties and responsibilities before they start the clinical trial.

How you’ll know when you can check this off your list and move on to the next step:

• When all participants have reviewed, signed, and acknowledged their responsibilities and associated risks in writing, you can move on to the next step.

Collecting and Reporting Data for Clinical Trials

• Establish a system for tracking, collecting, and reporting data used in the clinical trial
• Decide on what type of data will be collected, how often it will be collected, and how it will be reported
• Acquire the tools needed to collect the data and create a detailed data collection plan
• Develop a data analysis and reporting system
• Create a log of data points to ensure accuracy
• Establish quality assurance processes for collecting, analyzing, and reporting data
• Train personnel on data collection processes
• When all of the above is completed and tested, you can move on to the next step.

Setting up a system to collect and store data

• Create a database to store collected data
• Design data entry forms to capture all relevant data
• Select a secure electronic system to store trial data
• Establish protocols to ensure accuracy and integrity of data
• Establish rules around backup and archival of data

You can check this step off your list once you have created the database, designed data entry forms, selected a secure electronic system, established protocols, and established rules around backup and archival of data.

Establishing processes to ensure accuracy of data

• Create a quality assurance plan that outlines the processes and procedures for ensuring accurate data collection and reporting
• Develop and document audit procedures for data review and validation
• Create processes for data analysis to identify and address any errors
• Ensure the accuracy of the data collected and reported through regular audits
• When the quality assurance plan is complete and the audit procedures are in place, you can move on to the next step of reporting the data according to the protocol.

Reporting the data according to the protocol

• Ensure that you have all the documents you need to report the data according to the protocol
• Establish a process for collecting, entering, and managing data according to the protocol
• Create a system for auditing data to make sure it is accurate
• Generate reports that are in accordance with the protocol
• Once all the data is reported and verified, you can move on to the next step.

Monitoring and Auditing Clinical Trials

• Establish a monitoring plan for the clinical trial
• Designate qualified personnel to monitor the trial
• Establish a process for auditing the trial
• Establish a system for managing and monitoring adverse events
• Formalize a process for collecting and documenting data
• Develop a system for tracking changes to the protocol
• Develop a system for tracking changes to data collection
• Identify internal and external audit risks
• When all of the above steps have been completed, you can move on to the next step of setting up a system to monitor adherence to protocol.

Setting up a system to monitor adherence to protocol

• Set up a monitoring plan that outlines the activities you’ll use to assess compliance with the protocol
• Determine which documents you need to document adherence to the protocol and create a document tracking system
• Create checklists for tracking activities like protocol deviations, serious adverse events, and concomitant medications
• Verify that all documents that need to be tracked are being tracked and reported in the system
• When you’ve established the system to track adherence to the protocol, you can move on to the next step.

Ensuring protocol compliance and accuracy of data

• Review all clinical trial documents such as protocols, investigator brochures, informed consent forms, and other regulatory documents to ensure accuracy
• Ensure that all documents are compliant with applicable regulations
• Make any necessary changes to ensure accuracy and compliance
• Create a tracking system to monitor the accuracy and compliance of documents throughout the course of the clinical trial
• When you can ensure accuracy and compliance of documents, move on to the next step: performing regular audits to identify and address issues.

Performing regular audits to identify and address issues

• Develop audit plans for all clinical trials
• Establish and document processes for conducting audits
• Create and implement a system for tracking and documenting audit findings
• Define criteria for determining audit findings
• Establish protocols for responding to audit findings
• Create a process for tracking corrective and preventive actions
• Ensure that all corrective and preventive actions are completed
• Review audit results and document any corrective and preventive actions taken
• When all action items have been addressed and all audit findings have been resolved, the audit is complete.

Guidelines for Closing Clinical Trials

• Gather all documentation related to the clinical trial, such as source documentation, protocols, data collection forms, and other related documents
• Review all participant data to ensure accuracy and compliance with the protocol
• Collect all data from participating sites and ensure accuracy
• Submit all required documents to the regulatory authority in accordance with applicable regulatory requirements
• Submit a final report to the sponsor
• Archive all documents related to the trial
• When all documents have been collected, reviewed, and submitted, the trial can be officially closed.

Generating a final report

• Collect all documents related to the clinical trial, including signed informed consent forms and other protocols
• Review the data to check that all data points have been collected and recorded accurately
• Collect the participant’s feedback and experiences while participating in the study
• Generate a summary of the results and any unexpected findings
• Create a final report that outlines the study’s results, conclusions, and recommendations
• Submit the final report to the relevant authorities
• Once the report has been approved, the clinical trial is considered closed
• Check off this step to indicate that you have generated the final report for the clinical trial.

Verifying that all data points have been recorded

• Review all the data collected from the trial to confirm that all data points have been recorded.
• Carefully check the data to make sure that all data points are accurate and up-to-date.
• Cross-check the data with the original research objectives to confirm that all relevant data points have been covered.
• Check for any discrepancies between the original research objectives and the data collected.
• Once you have ensured that all data points have been recorded and that any discrepancies have been resolved, you can move on to generating a final report.

Ensuring all participants have completed the trial

• Check with the research team that each participant has completed all required tests and questionnaires.
• Verify that all participants have returned signed consent forms.
• Ensure that the research team has the contact information for all participants in case of any follow-up questions or inquiries.
• Confirm that each participant has been given their payment or compensation for their time.
• You will know that this step is complete when you have verified that all participants have completed the trial and been compensated for their time.

Potential Challenges and Solutions for Clinical Trials

• Identify any potential challenges that may arise during the clinical trial process and develop strategies to address them
• Consider potential risks associated with clinical trial procedures, such as the possibility of a participant’s health deteriorating during the trial
• Identify any ethical issues that may arise, such as informed consent and patient confidentiality
• Develop strategies to ensure that all participants are aware of the risks associated with the trial and have given their informed consent
• Develop strategies to protect the participant’s privacy and confidentiality
• Develop contingency plans to address any unanticipated challenges
• Develop a monitoring plan to ensure that all participants are adhering to the protocols of the trial

You will know this step is complete when you have identified any potential challenges that may arise during the clinical trial process and have developed strategies to address them.

Identifying potential challenges

• Review literature and data from past clinical trials to identify potential risks
• Review regulations related to the trial for additional potential risks
• Assess potential risks associated with the trial based on its timeframe
• Analyze patient population and any potential risks associated with them
• Identify any potential risks associated with study team or equipment
• Review any potential risks caused by the study design

When you have identified all potential risks of the clinical trial, you can check off this step and move on to the next step of developing strategies to mitigate risk.

Developing strategies to mitigate risk

• Identify the risk factors associated with the clinical trial and develop strategies to mitigate them
• Assess the severity of the risks and prioritize the strategies accordingly
• Develop strategies that focus on prevention, detection and reaction
• Establish monitoring techniques to monitor the risks
• Develop strategies to address each risk identified
• Document the strategies and procedures for mitigating the risks
• When strategies and procedures for mitigating risks have been established, the step can be checked off the list and the next step can be addressed.

Developing contingency plans for unexpected events

• Identify potential areas of risk
• Assess the potential impact of each area of risk
• Develop contingency plans to minimize the risk in each area identified
• Test the effectiveness of these contingency plans
• Document the contingency plans and store in a secure and easily accessible location
• Make sure all stakeholders are aware of the contingency plans
• Reassess and update the contingency plans as necessary

You can check this off your list when all the contingency plans have been identified, tested and documented in a secure location.

Dissemination of Results

• Track the progress of the clinical trials and prepare a timeline for publication of results
• Collect all data generated during the trial and analyze it using statistical methods
• Draft a manuscript summarizing the results of the trial
• Compile any supplementary materials such as tables, figures, and appendices
• Submit the manuscript to peer-reviewed journals
• Participate in the peer review process and revise the manuscript based on reviewers’ comments
• Publish the paper once it has been accepted by the journal

Once all steps have been completed and the paper has been published, you can check this off your list and move on to the next step.

Publishing results in peer-reviewed journals

• Identify a peer-reviewed journal that is appropriate for your clinical trial results and submit your manuscript
• Ensure that the manuscript is compliant with the journal’s guidelines and formatting requirements
• Follow the review process, making any revisions and corrections as needed
• Once accepted, publish the results of the clinical trial in the peer-reviewed journal
• Track the progress of the publication to ensure that it is in line with the journal’s timeline
• You will know when you can check this off your list and move on to the next step when the publication is finalized and printed in the journal

Presenting findings at conferences

• Select the pertinent data to present at the conference
• Draft a presentation with the help of the team
• Submit the presentation to the conference organizers
• Prepare materials needed for the presentation
• Attend the conference and present the findings
• Answer questions and engage with other attendees
• Make necessary changes to the presentation based on feedback
• You will know this step is complete when you have presented your findings at the conference.

Sharing results with relevant stakeholders

• Prepare a summary of the clinical trial results to share with stakeholders
• Distribute the summary to relevant stakeholders such as sponsors, investigators, and ethical review boards
• Notify stakeholders of any changes in the study protocol or data
• Follow up with stakeholders to ensure that they have received and understood the summary
• Ensure that all stakeholders comply with relevant regulations and guidelines
• Obtain any required approvals from stakeholders
• Check off this step once you have received all the required approvals and stakeholders have given their consent.

FAQ:

Example dispute

Suing a Pharmaceutical Company for Illegal Clinical Trials

• A plaintiff may sue a pharmaceutical company for conducting illegal clinical trials that resulted in physical or mental harm to the plaintiff.
• The plaintiff must prove that the company was negligent in conducting the trial, and that the negligence was the direct cause of the harm.
• The plaintiff must also prove that the company failed to meet the appropriate standard of care as outlined in relevant regulations, statutes and civil law.
• Depending on the severity of the harm, the plaintiff may seek compensatory damages, including payment for medical expenses and lost wages.
• The plaintiff may also seek punitive damages if the pharmaceutical company’s conduct was particularly egregious.
• In some cases, the parties may reach a settlement agreement, which typically includes a full or partial release of liability in exchange for payment or some other form of compensation.
• The court may also award damages depending on the circumstances, including lost wages, medical expenses, and pain and suffering.

Templates available (free to use)

Clinical Trial Contract Institution Friendly
Clinical Trial Contract Sponsor Friendlying Party
Clinical Trial Contract Sponsor Friendlying Party Simple
Clinical Trials Informed Consent Template
Clinical Trials Representations Warranties For Life Sciences Companies
Contract Research Organization Master Services Contract For Clinical Trial Support Sponsor Friendly
Investigator Initiated Clinical Trial Contract Commercial Friendly Entity
Investigator Initiated Clinical Trial Contract Institution Friendly

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