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In conducting clinical research, a researcher must have Good Clinical Practice (GCP) certification as one of the eligibility requirements for a study. This is what prompted the Health Research Ethics Commission (KEPK) of the Faculty of Medicine (FK) Universitas Sebelas Maret (UNS) to hold a Good Clinical Practice Certification Workshop.

The activity which was held in the Ballroom of the Tower Ki Hadjar Dewantara Building UNS, lasted for 2 days on 26-27 June 2023. It was opened by the Dean of FK UNS, Prof. Dr. Reviono, dr., Sp.P(K), this activity was attended by Educators, Masters and Doctoral students at UNS and practitioners from Dr.Moewardi Hospital and UNS Hospital.

This activity presented 2 speakers from outside UNS namely dr. Jarir At Thobari, D.Pharm., Ph.D from Gadjah Mada University and Dr. Rizaldy Taslim Pinzon, dr., M.Kes., Sp.S from Duta Wacana Christian University.

Dr. Rizaldy, who presented material on Good Documentation Practice, said that all research documentation must be clear and written as it is.

“Everything that is not documented or recorded is considered to have never happened. There should be no assumptions because I didn't write it down, that means it didn't happen, so if it doesn't happen, it still has to be written as nothing and if it isn't done, it isn't done," he explained.

"Actually, GCP is an international standard so that clinical trials involving human subjects are carried out properly. So that the research carried out can be scientifically justified and on the one hand does not violate ethical principles," he continued.

Dr. Rizaldy also highlighted the importance of patient or subject safety in a study.

"Patient safety, subject welfare is above all. He must be protected to ensure that the drug or test product or device being developed is truly safe or safe for the subject. On the other hand, we must ensure that the data we get from this research is valid and reliable," he explained.

Head of the UNS FK Research Ethics Commission and Chair of the Organizing Committee for this activity, Tri Nugraha Susilawati, dr., M.Med., Ph.D said that this training aims to increase the understanding and awareness of researchers about good clinical trials in accordance with the basic principles of GCP, namely Prioritize ethics and quality.

"Through this training, it is hoped that we can understand the principles of GCP, we can learn about protecting participant rights, identifying unwanted events, and being able to understand the importance of reporting honest and transparent data," dr. Tri Nugraha explained.

It is hoped that this training can strengthen participants' understanding and commitment in carrying out research so that they can provide benefits and be responsible and respect the rights of participants.

 

Reporter: Muh. Abu Dawud
Editor & Translator: Wartini