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Frequently Asked Questions



Clinical trials offer hope for many people while giving researchers a chance to find treatments that could benefit patients in the future. Healthy volunteers say they take part to help others and contribute to moving science forward. People with an illness or disease may take part to help others but also to have a chance to receive the newest treatment and get added care and attention from the clinical trial staff.

Clinical trials may involve risk, as can routine medical care and the activities of daily living.

What is clinical trial insurance?

Clinical trials are crucial for evaluating the effectiveness and safety of drugs, devices, services, and interventions to help prevent, detect or treat illness and disease. It is through the research done in clinical trials that people gain access to better treatments.

Clinical trial insurance is referred to as ‘no-fault’ liability insurance coverage, taken by responsible parties involved in the clinical trial, to respond to a claim of harm or injury suffered by a trial volunteer, as a direct result of their participation in such a trial.

Why is clinical trial insurance required?

In terms of the responsibilities of the sponsor/applicant as described in the current Good Clinical Practice (GCP) Guidelines, all sponsors/applicants and investigators of clinical trials must have adequate comprehensive insurance to cover for any liability claim during the conduct of a clinical trial with exception for claims that arise from malpractice and/or negligence This guidance document of the South African Health Products Regulatory Authority (SAHPRA) seeks to clarify the requirements for such insurance for purposes of making a submission for approval of a clinical trial by SAHPRA.

Evidence of comprehensive no fault insurance for serious injury and harm and/or death should be provided by the sponsor and/or applicant.

Sponsor/applicant should take responsibility of ensuring that participants are fully compensated.

Would having clinical trial insurance play a role in getting permission / funding for a clinical trial?

The clinical trial insurance plays an important part in the process, without having insurance the Clinical Research Organisation who applies for funding will not be able to complete the process.

How specialised is our product and is it difficult to secure?

Clinical trials are a very specialist market, for which many local insurers need international re-insurance partners. We only have a hand-full of brokers and insurers that partake in this liability market.

Why are clinical trials designed?

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives.

Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3/4 studies.

Requirements to Quote

Proposal Form


Signed Consent Forms

What limits of Indemnity does CT Sure offer?

The current limits offered is the industry norm and complies with SAHPRA requirements and Insurance Industry Statistics. These limits are approved by the SAHPRA.


Indemnity Limit

Per Trial


Per Suject

Observational Studies R1,000,000 R100,000
Market Standard R10,000,000 R1,000,000
Communication Costs R100,000  
Loss of Earnings R100,000  

Excess Structure:

  • R25,000
  • R10,000
  • Waived at an additional premium.
When must the client pay the premium?

Premium must be paid before inception of the policy.

What are some of the risks that come with clinical trials?

Most clinical trials pose the risk of minor discomfort, which often lasts only a short time. However, some study participants experience complications that require medical attention.

In rare cases, participants have experienced serious or life-threatening complications resulting from their participation in trials of experimental treatments.

The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.

In clinical trials that compare a new product or therapy with another that already exists, researchers try to determine whether the new one is at least as good as the existing one. In some studies, you may receive a placebo. Comparing a new product with a placebo can be the fastest and most reliable way to show the new product’s effectiveness. However, placebos are not used if participants would be put at risk — particularly in the study of treatments for serious illnesses — by not having effective therapy. However, this is highlighted in the protocol and rated accordingly.

What is not covered?
  • Any claim prior to inception date of the policy or any circumstance known to the insured at inception which could have been foreseen to give rise to a claim.
  • Claims that are covered by another policy – i.e., medical malpractice / professional indemnity.
  • The excess / deductible noted in the schedule or certificate.
  • Any dishonest, fraudulent, or criminal acts.
  • Any pre‐existing conditions of which the Research Subject failed to advise.
  • Genetic manipulation of tissue or the infliction of genetic injury.
  • Any invasive methods used during the clinical trial.
  • Research Subjects who are under 18(eighteen) years of age, unless agreed by the Company and stated in the schedule or certificate to be included.
  • Negligent acts by the medical practitioners or negligent administration by the clinical research organisation by not following the set protocol.
How does a participant submit a claim?

All claims must be submitted by the participant, through the Clinical Research Organisation / Investigator, as soon as reasonably possible. This can be done in writing or verbally. It is the responsibility of the Clinical Research Organisation / Investigator to notify CT Sure of any possible losses, as soon as they become aware thereof. Please note that each circumstance is considered on its own merits, and there is therefore no set claims guideline. Whatever information CT Sure require will be requested on assessment of each claim.

Documentation required for a claim:
  • Details of the Insured and Policy number
  • All available information concerning the circumstance, including how, when and where it happened.
  • All available names and addresses of any party who has suffered injury, loss or damage and of all available witnesses.
  • Full Details of the clinical trial
  • All documents provided to the Participant.
  • All documents signed by the Participant.
  • Details of the injury suffered by the Participant.
  • Whether the injury was a known side effect or circumstance as part of the trial
  • Whether the insured was negligent in any way towards the Participant.
Who will be indemnified?

Settlement can only be made to the participant of the trial for damages due to the drugs tested in the trial.

How long does a claim take to be paid?

Each claim will be different and will be handled on a case for case basis.


Liability insurance in clinical trials refers to the insurance or indemnity covering the liability of the sponsor/applicant and/or the investigator in respect of claims made against them by the participants with respect to injury attributable to their participation in a clinical trial.

The current GCP guidelines provide broad guidance regarding injuries (including death) for which insurance would be required. These requirements were developed taking into consideration the current Association of the British Pharmaceutical Industry’s (ABPI) clinical trial compensation guidelines.

There is an international consensus that research participants who suffer injury because of their participation should be provided medical treatment at no cost to themselves or their families. Such financial or other assistance should compensate them equitably for any medical treatment for resultant impairment, disability, or handicap. In the case of death because of their participation, their dependants are entitled to compensation.

Who is covered?

Cover is intended for the participants of the trial who may suffer injury because of their participation. The main parties involved in clinical trials are as follows:

  • Research subjects who are registered as participants in the insured trial.
  • Pharmaceutical Company.
  • Clinical Research Organisation (the managing organisation of the clinical studies).
  • Institute at which the trial is administered.
What is No Fault Basis?

No Fault Basis means that the Research Subject is entitled to compensation without having to prove negligence on the part of the administers of the clinical trial.

What are the benefits of clinical trials?

Well-designed and well-performed clinical trials provide benefits to the participant while allowing the participants to help others by contributing to knowledge about new treatments or procedures.

Participants gain access to new research treatments before they are widely available.

Participants receive regular and careful medical attention from a research team that includes doctors and other healthcare professionals.

Why is it required by SAHPRA to have participants in observational studies insured?

Limits are determined by risk.

i.e., observational studies may select a lower limit of indemnity which attracts a lower premium.

4 Phases of Clinical Trials:

Phase 1

 Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months.

Purpose: Safety and dosage.

Approximately 70% of drugs move to the next phase. 

During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer.

Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are.

As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This is important to the design of Phase 2 studies.

Phase 2

Study Participants: 100 – 500

Length of Study: Several months to 2 years.

Purpose: Efficacy and side effects.

Approximately 33% of drugs move to the next phase.

In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few hundred patients, these studies aren’t large enough to show whether the drug will be beneficial.

Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.

Phase 3

Study Participants: 1000 to 3,000 volunteers who have the disease or condition.

Length of Study: 1 to 4 years.

Purpose: Efficacy and monitoring of adverse reactions.

Approximately 25-30% of drugs move to the next phase.

Required to approve the drug to be used.

Researchers design Phase 3 studies to demonstrate whether a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.

Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects.

Phase 4

Study Participants: Several thousand volunteers who have the disease/condition.

Purpose: Safety and efficacy.

Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring.

How does the premium get calculated?

Premiums are based on various factors as follows:

  • Type and phase of trial.
  • Proven negative effects of drug being used and tested.
  • Age of the participants (specifically under the age of 18).
Additional Cover included in the product?
  • Communication and Mitigating Reputational damage cost up to a limit of R100,000-00
  • Loss of earnings in respect of all Research Subjects up to a limit of R100,000-00
What is the initial cover period offered for clinical trial insurance?
  • Clinical insurance cover is provided up to 12 months and is then renewed after 12 months.
Is CT Sure able to extend cover for 24 or 36 months?

Some trials are underwritten and issued for the full period of the trial, which may be 24 or 36 months, but this is on discretion of the underwriters.

Would there still be a claim if a participant has provided their informed consent to participate in a clinical trial and harm is suffered?

Yes, clinical trial policies are written on a no- fault basis. 

When does the insurance cover incept and when will it be renewed?

Clinical trial insurance cover incepts once the first date of clinical testing commences and is then renewed after 12 months.

Will the policy respond if the damages are due to a known side effect?

Known side effects are covered if it was mentioned in the protocol supplied at quoting stage.

Is there a specific time frame in which CT Sure must be notified by the client?

The Insured must give written notice to CT Sure of any claim or proceedings immediately or as soon as practicable possible after such claim or proceedings come to the knowledge of the Insured and shall, as soon as practicable, forward to CT Sure every pre-action letter, demand, notice, summons, claim form or other process received by the Insured.

  • Phone: 012 941 2147
  • Email:
  • Address: 1020 Pretorius Avenue South, Lyttelton Manor, Centurion, 0157