Meeting Regulatory Compliance for Clinical Trials

The regulatory environment in which a pharmaceutical or medical device company operates places controls under which trials are conducted. Becoming very familiar with these regulations is a fundamental stage in the trial process. When an International company is conducting the trial the question of translation also becomes part of the equation.

Categories of clinical trials include:

  • Treatment trials
  • Prevention trials
  • Diagnostic trials
  • Screening trials, and
  • Quality of life trials

International medical companies intending to market and sell in the US

Although only a minority of drugs initially created and seeking approval succeeds in reaching clinical trials translation of documents may still be a requisite. Once a drug enters Patent & Associated documents and becomes public, translations may be advisable. With so many drugs being created at times companies question whether their patents have been violated and begin patent litigation. Litigation may also arise regarding patent protection if other companies or parties believe that the drug or device is already in the public domain.

When a clinical trial reaches the approval stage an institutional review board, or ethics committee, reviews the:

  • Clinical Trial Protocol;
  • Patient Information Sheet;
  • Informed Consent Form;
  • Case Report Forms (CRF's);
  • Possibly Patient Questionnaires.

Common to this stage of a clinical trial is extensive correspondence. The principle investigator will be expected to provide personal information, perhaps in the form of curriculum vitae, verifying the qualifications and background necessary to perform a clinical trial at this level. Furthermore, extra material is provided to establish the financial, legal, and other ties between the principal investigator and sponsor of the trial. Documents of this nature may need translation along with the letters that would accompany them. When the approval of a trial becomes more likely the principal investigator will choose assisting investigators and other personnel whose CV's will also be submitted to the Institutional Review Board.

Contracts are drafted for the investigators and the institutions for which they work. Whilst the toxicity of the drug is tested in lab animals and safe doses for human volunteers are determined during phase 1, trial related papers will need to be translated into English.

When the trial moves on to the next phase and the patients are selected, the files from their regular physicians should be provided in English so as to fully inform the investigators of their background health. In addition, Case Report Forms require translation as well as comparisons with CRF's and legacy patient files.

Throughout the lab process, Lab reports are generated creating more material to be translated. In the event of strong side effects a Serious Adverse Event (SAE) report may arise, or for milder less threatening side effects a Lab Report. The results for drug testing in one country must be recorded accurately so that it can be referenced with results from clinical trials in other countries.

On conclusion of the trial a Clinical Trial Report is composed. If successful, the drug or device will then go through the validated manufacturing process.

The FDA must approve of all devices. The manufacturing process is accompanied by substantial detailed paperwork. Approval must also be sought for Manuals, Product Labels, Packaging, and Inserts. Devices or drugs previously approved in another country may not face trials from scratch but will still need to provide all relevant paperwork, manufacturing documents, etc. Technical Product Information Sheets, as with Package Inserts, are translated and updated every 5 years. Outstanding information published more than 5 years previously can also be updated at this point.

Existing documentation could be used for other related purposes. Health surveys may benefit from the patient questionnaires, and toxicology reportsmay inform public health or industrial workplace medicine.

Medical information should be available to the public, patients, and their families. The most likely Media for access are

  • Web sites
  • Brochures, Pamphlets
  • Public Information Campaigns
  • Direct Mail-Outs
  • Newsletters

The National Institute of Health has developed a consumer-friendly database, www.ClinicTrials.gov, to provide the public, patients, and their families with up-to-date information regarding clinical research studies.

Providing translations does not have to be a burdensome time consuming activity. By carefully selecting a professional experienced translation partner you can place your documents in the hands of specialists who can take care of the entire process for you. In doing so, you can reduce time to market and start realizing your ROI. To find out more about the quality assured service AbroadLink can provide call one of our representatives on 1800 880 5709.


The content of this article is general in nature and is not intended as business or legal advice related to an individual situation. Counsel should be consulted for specific planning and advice.