How To Disclosure Clinical Trial in 5 steps

 Ben Goldacre says:

For science has influence! This is not due to white coats or titles, but rather to accuracy and transparency, where you explain your theory and provide your evidence and reference to studies that can support your cause.

WHO requirements and complex work are important to disclose the results of clinical trial. Whereas, the time is required to disclose the results of clinical trials will published on April 14, 2015, By The WHO statement.

The Food and Drug Administration Amendments Act 2007, requires from representatives to disclose the results of completed clinical trials in accordance with specific timeframes on the following site:

ClinicalTrials.gov

The European Union is imposes regulations Policy (70) and emphasizes the needed to publicly disclose the results of clinical trials in the general database of the European Union. Regardless of these regulations, many countries around the world have their own regulations to disclose the results of clinical trials, Even that some countries have more than one record or database for this matter.

We see that the disclosure of clinical trials, It became known for all. Currently, those responsible for multinational clinical trials must organize clinical trials disclosures according to international and national guidelines.

The process of disclosure includes some difficulties such as collecting data from different sources, validating data and entering a record, tracking the process and preventing duplication of multiple results and maintaining schedules in all records.

Since this field is under development, the international and national laws will overlap and it is expected that there will be repetition of results for some time, so it is important to achieve an integrated process specifically designed to reduce the risk of data inconsistency and non-compliance.

The following five steps will help to reduce errors and increase efficiency.

  1. Plan: A gap analysis should be performed to determine which of the records are applicable. It is also necessary that the requirements are detailed such as initial registration, status update frequency (for example: enrollment status), and results disclosure is necessary. Remember—failing to plan is only a plan for failure.
  1. Collect: Import the largest possible number of data from its source, and in addition, the requirements of registration should be paid attention to when transmitting to the public and translating into local languages. To this end, a registry-specific data set should be created from the data sources and standardized according to registry specifications.
  1. Validate: Verify and inspect the data collected before submission, a quality inspection should be performed to verify the validity of the data according to the data against registry-specific validation rules and company-specific edit checks. Some records such as: gov or EudraCT have a number of edit checks. That helps us to be ensured.

 

  1. Upload: At this point, the data is ready to be submitted to the registries. Check if the registry supports automatic entry or if manual entry of the data is required. If the registry supports files, the automatic entry will be much easy. However, if the file requires manual entry of data, so the report will showing the data in the order required by registration will make it easier to copy and paste.

 

  1. Track: The status of each record is tracked and knowledge of what the next steps require action, processing of late records, registry feedback, and outstanding comments.

 

Following these five key steps can make disclosure easier. In addition, We recommend that a set of tools be developed that is routinely

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