eTMF: your ally in Clinical Trial document control
28-06-2023
What does the TMF include?
The TMF is a compilation of documents, at the study, country, and site levels, collected from the start to the closure of the CT. The TMF is essential to comply with the Good Clinical Practice (GCP) described by the International Conference on Harmonization, ICH E6, and is a requirement of regulatory agencies, such as the European Medicines Agency or the FDA. Thus, the TMF plays a crucial role in ensuring that the investigator, the sponsor, and the site have successfully managed a trial, allowing to assess the study conduct and data collection quality.
All the documents included in the TMF must be available to the sponsor for audit or inspection by regulatory authorities. Given the large volume of documents, its management can significantly impact the cost and time to complete a CT.
Do I need an eTMF for my CT?
According to the first paragraph of item 7 of Article 43 of Chapter IX (Good clinical practice standards) of Royal Decree 1090/2015, of December 4, regulating clinical trials with drugs, the Drug Research Ethics Committees and the Spanish Clinical Trial Registry, “The media used to store essential documents shall be, in general, in electronic form, and shall ensure that documents remain complete and legible during the established retention period, as well as available to the competent authorities upon their request. Any changes to the records must be traceable, allowing to retrieve the initial and the corrected information, as well as the date and the author’s signature.”
The need for an eTMF will depend on whether the research is carried out independently or as part of a study whose sponsor is external to the organization. Organizations that outsource all their trials usually depend on CROs (contract research organizations) to manage the TMF for their ongoing trials. CROs are the ones that have the application used to manage the TMFs of all participating sites. Upon trial completion, the CRO usually delivers the TMF to the sponsor, who will ensure its integrity and accessibility for an extended period, usually 25 years or longer.
Companies such as Ennov offer advanced systems allowing investigators and research units to take control of their clinical trial documentation, ensuring they are always available for inspection. Through their metrics, a quick view allows for verifying whether goals are being met and identifying and addressing the cause of any issues.
Among the advantages offered by Ennov eTMF stands out its high configurability with no need for IT expertise, metadata-based document model, easy and intuitive searching capabilities, scalability and security, a folder structure for the standard TMF template, powerful search features that facilitate inspections by health authorities, and highly profitability. Since it is a read-only file, the user assessment and training time is considerably reduced.
The TMF is a compilation of documents, at the study, country, and site levels, collected from the start to the closure of the CT. The TMF is essential to comply with the Good Clinical Practice (GCP) described by the International Conference on Harmonization, ICH E6, and is a requirement of regulatory agencies, such as the European Medicines Agency or the FDA. Thus, the TMF plays a crucial role in ensuring that the investigator, the sponsor, and the site have successfully managed a trial, allowing to assess the study conduct and data collection quality.
All the documents included in the TMF must be available to the sponsor for audit or inspection by regulatory authorities. Given the large volume of documents, its management can significantly impact the cost and time to complete a CT.
Do I need an eTMF for my CT?
According to the first paragraph of item 7 of Article 43 of Chapter IX (Good clinical practice standards) of Royal Decree 1090/2015, of December 4, regulating clinical trials with drugs, the Drug Research Ethics Committees and the Spanish Clinical Trial Registry, “The media used to store essential documents shall be, in general, in electronic form, and shall ensure that documents remain complete and legible during the established retention period, as well as available to the competent authorities upon their request. Any changes to the records must be traceable, allowing to retrieve the initial and the corrected information, as well as the date and the author’s signature.”
The need for an eTMF will depend on whether the research is carried out independently or as part of a study whose sponsor is external to the organization. Organizations that outsource all their trials usually depend on CROs (contract research organizations) to manage the TMF for their ongoing trials. CROs are the ones that have the application used to manage the TMFs of all participating sites. Upon trial completion, the CRO usually delivers the TMF to the sponsor, who will ensure its integrity and accessibility for an extended period, usually 25 years or longer.
Companies such as Ennov offer advanced systems allowing investigators and research units to take control of their clinical trial documentation, ensuring they are always available for inspection. Through their metrics, a quick view allows for verifying whether goals are being met and identifying and addressing the cause of any issues.
Among the advantages offered by Ennov eTMF stands out its high configurability with no need for IT expertise, metadata-based document model, easy and intuitive searching capabilities, scalability and security, a folder structure for the standard TMF template, powerful search features that facilitate inspections by health authorities, and highly profitability. Since it is a read-only file, the user assessment and training time is considerably reduced.
