Data Collection

What it means to comply with GCP guidelines in clinical research

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Deborah Maufi's profile picture
Deborah Maufi
on
Sep 17, 2018

Dear Diary,

I have been struggling with an eating disorder for the past few years. I am afraid to eat and afraid I will gain weight. The fear is unjustified as I was never overweight. I have weighed the same since I was 12 years old, and I am currently nearing my 25th birthday. Yet, when I see my reflection, I see somebody who is much larger than reality.

I told my therapist that I thought I was fat. She said it was 'body dysmorphia'.
She explained this as a mental health condition where a person is apprehensive about their appearance and suggested I visit a nutritionist. She also told me that this condition was associated with other anxiety disorders and eating disorders. I did not understand what she was saying as I was in denial; I had a problem, to begin with. I wanted a solution without having to address my issues.

Upon visiting my nutritionist, he conducted an in-body scan and told me my body weight was dangerously low.

I disagreed with him.

I felt he was speaking about a different person than the person I saw in the mirror. I felt like the elephant in the room- both literally and figuratively. He then made the simple but revolutionary suggestion to keep a food diary to track what I was eating.

This was a clever way for my nutritionist and me to be on the same page. By recording all my meals, drinks, and snacks, I was able to see what I was eating versus what I was supposed to be eating. Keeping a meal diary was a powerful and non-invasive way for my nutritionist to walk in my shoes for a specific time and understand my eating (and thinking) habits.

No other methodology would have allowed my nutritionist to capture so much contextual and behavioural information on my eating patterns other than a daily detailed food diary.
However, by using a paper and pen, I often forgot (or intentionally did not enter my food entries) as I felt guilty reading what I had eaten or that I had eaten at all.

I also did not have the visual flexibility to express myself through using photos, videos, voice recordings, and screen recordings. The usage of multiple media sources would have allowed my nutritionist to observe my behaviour in real-time and gain a holistic view of my physical and emotional needs.

I confessed to my therapist my deliberate dishonesty in completing the physical food diary and why I had been reluctant to participate in the exercise. My therapist then suggested to my nutritionist and me to transition to a mobile diary study.

Whilst I used a physical diary (paper and pen), a mobile diary study app would have helped my nutritionist and me reach a common ground (and to be on the same page) sooner rather than later.

As a millennial, I wanted to feel like journaling was as easy as Tweeting or posting a picture on Instagram. But at the same time, I wanted to know that the information I  provided in a digital diary would be as safe and private as it would have been as my handwritten diary locked in my bedroom cabinet.

Further, a digital food diary study platform with push notifications would have served as a constant reminder to log in my food entries as I constantly check my phone. It would have also made the task of writing a food diary less momentous by transforming my journaling into micro-journaling by allowing me to enter one bite at a time rather than the whole day's worth of meals at once.

Mainly, the digital food diary could help collect the evidence that I was not the elephant in the room, but rather that the elephant in the room was my denied eating disorder.

Sincerely,
The elephant in the room

Clinical research is crucial in determining the safety and efficiency of medication and other healthcare practices intended to be used on human beings. Clinical research is imperative to society since studies add to general medical knowledge. Most of what we know today came to light because of medical research devised to answer important scientific and health care controversies and questions. It can give crucial information about disease patterns, risk factors, results of treatment or public health interventions, practical capacities, trends and patterns of care, and health care expenses and patient and healthcare workers’ perceptions (Vijayananthan, A., & Nawawi, O. 2008).

Clinical research opens ways of advancing prevention, medications and treatment solutions for healthcare problems. Clinical research demonstrates what does and doesn't work in individuals. For this to work, clinical studies use research with human participants who are fundamental to this advancement. Because of this, every researcher intending to use human participants in their research must ensure that the study complies with certain regulations that protect the human subjects which help reduce the risks that medical research bears. These regulations are known as Good Clinical Practice (GCP).

What is GCP and why is it important?

When you are engaged in clinical research designing and implementation, you ought to have the capacity to demonstrate that you know about the GCP rules.

Good Clinical Practice (GCP) is an ethical and quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials involving human subjects. It protects the rights and privacy of the participants.

GCP assures that the data and reported results are reliable and accurate and that the rights, integrity and confidentiality of study subjects are respected and protected.

Vijayananthan & Nawawi, 2008

GCP aims to ensure the following:

Subject safety: The human subject must feel safe at all times during the trial.

Subject rights are protected i.e:

  • Right to information
  • Right to choose not to participate
  • Right to withdraw from the trial at any time
  • Right to privacy and confidentiality

Quality data that is based on a scientific logical protocol designed to meet its objectives and can be used for regulatory decision-making.

When did it all begin?

Involvement of human subjects in medical research became part of the American political agenda since the early 1900s. Before the Pure Food and Drugs Act in 1906, the first landmark event in food and drugs regulation, all drugs were sold like any other consumer goods. Unsafe drugs could easily be brought into the market leading to serious adverse effects and/or mortality. For the first time, in 1938, manufacturers were obligated to test drugs, food or cosmetics for safety and present the evidence to FDA prior to marketing. This was known as the Federal Food, Drug, and Cosmetic Act.

The Declaration of Helsinki, which is considered a key document on the ethical principles that underlie GCP, was first developed by the World Medical Association (WMA) and adopted in June 1964, at the 18th World Medical Assembly in Helsinki, Finland. The Declaration of Helsinki has been revised and updated several times since then, most recently in October 2000, at the 52nd WMA General Assembly in Edinburgh, UK. It is supported by 190 nations around the world (Otte A, et al. 2005). In April 1979 the Belmont Report was issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. (Vijayananthan, A., & Nawawi, O. 2008). The principles of this report are as follows:

  • Respect for Persons: This principle acknowledges the dignity and freedom of every person. It requires acquiring informed consent from study subjects (or their lawfully approved representatives).
  • Beneficence: This principle requires that researchers maximize benefits and minimize risks associated with research. The benefits must outweigh the research-related risks.
  • Justice: This principle requires equity in selection and recruitment and fair treatment of research subjects.

In 1982, the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) released a document entitled ‘International Guidelines for Biomedical Research Involving Human Subjects‘ to help developing countries apply the principles of the Declaration of Helsinki and the Nuremberg Code. The guideline was issued globally. This led to organizations worldwide to release various versions of the issue.

In an effort to avoid GCP inconsistencies, a decision was made to consolidate all these guidelines. The International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was then held and issued the ICH Guidelines which was approved on 17 July 1996 and implemented for clinical trials from 17 January 1997. Representatives of authorities and pharmaceutical companies from the EU, Japan and the United States as well as those of Australia, Canada, the Nordic countries and WHO participated in the consolidation of these guidelines (European Medicines Agency).

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How is Teamscope compliant wih GCP?

Compliance with ICH GCP is one of the central requirement that clinical researchers refer to all over the globe. ICH GCP indicates the central importance of GCP for data management in clinical trials (Ohmann, C. et al, 2011). ICH GCP section 5 describes some requirements for the use of electronic data capture (EDC), e.g. the sponsors operating such computer systems must validate their systems, maintain SOPs for their use, ensure an audit trail for each data change and provide for data security (The International Council for Harmonisation, 1996). Below is a table showing how Teamscope complies with all the ICH GCP Data management Guidelines according to Section 5.5 of the manual:

1. Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation): ‍

Teamscope's form builder allows researchers to customize their eCRFs using skip logic, calculations, and field validation. Errors messages can be set up to alert researchers when the data entered is out of range or invalid.

2. Maintains SOPs for using these systems.

Teamscope maintains a user manual that covers the platform's functionality and features.

3. Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).

Users cannot delete data on Teamscope, only modify it or archive it. The study administrator may view an audit trail of all changes to research data and eCRFs.

4. Maintain a security system that prevents unauthorized access to the data.

Users require a unique username and password to authenticate, sessions across all platforms timeout after a limited time. To view a eCRF and/or study data a user requires study-specific permissions. Data-at-rest is encrypted using 256-bit AES and data-in-transit is communicated using TLS 1.2. Every day all data is backed up on redundant servers.

5. Maintain a list of the individuals who are authorized to make data changes.

A permission-based system is in place. Study administrator create granular permissions to individual users as well as groups of users.

6. Maintain adequate backup of the data.

We have automatic daily backups and standard operating procedure (SOP) to restore our databases.

7. Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing).

By using our permissions-based access system, the users of a study may be blinded from specific data elements or eCRFs.

8. If data are transformed during processing, it should always be possible to compare the original data and observations with the processed data.

All data changes on Teamscope are reflected in the Audit Trials report.

9. The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.

Every case and saved eCRF has a unique identifier, these identifiers helps researchers to minimize the risk of capturing data of a wrong study subject.

Conclusion

Clinical trials seek to answer questions that change over time and that are basic research progress problems they are intended to address. Prospective new treatments must be tried on human subjects keeping in mind the end goal to see if they succeed or cause harm. This is why GCP is important. It makes clinical research more effective, harmonized and ethical. Every research team must have a mentality that is significant in protecting patients' rights and guaranteeing data integrity. It is a direct result of the compliance of GCP guidelines that patients rights are protected. Amid any system, wellbeing and safety of the patients and also guaranteed. GCP also promotes data integrity and credibility.

Good Clinical Practice = Ethics + Quality Data

Teamscope offers strong data validation and protection with data ranges, audit trails, and encryption making your study data high quality and GCP compliant.


References

1. European Medicines Agency. ICH Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (PMP/ICH/135/95) London: European Medicines Agency; 2002

2. International Committee for Harmonisation Website https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

3. Malaysian Guidelines for Good Clinical Practice. 2nd edition. Ministry of Health Malaysia; 2004.

4. Ohmann, C., Kuchinke, W., Canham, S., Lauritsen, J., Salas, N., Schade-Brittinger, C., … Torres, F. (2011). Standard requirements for GCP-compliant data management in multinational clinical trials. Trials, 12, 85. http://doi.org/10.1186/1745-6215-12-85

5. Otte A, et al. Good Clinical Practice: Historical background and key aspects. 2005;26:563–74.

6. Vijayananthan, A., & Nawawi, O. (2008). The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomedical Imaging and Intervention Journal, 4(1), e5. http://doi.org/10.2349/biij.4.1.e5

7. World Health Organization http://www.who.int/medicines/areas/quality_safety/safety_efficacy/gcp1.pdf

Dear Digital Diary,

I realized that there is an unquestionable comfort in being misunderstood. For to be understood, one must peel off all the emotional layers and be exposed.

This requires both vulnerability and strength. I guess by using a physical diary (a paper and a pen), I never felt like what I was saying was analyzed or judged. But I also never thought I was understood.

Paper does not talk back.Using a daily digital diary has required emotional strength. It has required the need to trust and the need to provide information to be helped and understood.

Using a daily diary has needed less time and effort than a physical diary as I am prompted to interact through mobile notifications. I also no longer relay information from memory, but rather the medical or personal insights I enter are real-time behaviours and experiences.

The interaction is more organic. I also must confess this technology has allowed me to see patterns in my behaviour that I would have otherwise never noticed. I trust that the data I enter is safe as it is password protected. I also trust that I am safe because my doctor and nutritionist can view my records in real-time.

Also, with the data entered being more objective and diverse through pictures and voice recordings, my treatment plan has been better suited to my needs.

Sincerely,
No more elephants in this room

Deborah Maufi's profile picture

Deborah Maufi

I'm a business development specialist Teamscope. I enjoy helping our users do more and better clinical research. I'm a non-typical medical doctor and an above average board game fanatic.

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