Good Scientific Practice (GSP) Good Clinical Practice (GCP) Introductory Overview & Data Management
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1 (GSP) Good Clinical Practice (GCP) Beate Schwinzer
2 The Purpose of Science Science can explain why things happen Science leads to new knowledge Science serves the scientific community Science serves the entire society GSP 1 No. 2 of 31
3 The Process of Science Old Knowledge New Knowledge Hypothesis Publications Research GSP 1 No. 3 of 31
4 Feedback Mechanisms in Science Scientific Community and Society CONSOLIDATION (Reproduction, Teaching) New Knowledge Old Knowledge Scientific Community Hypothesis Scientific Community and Society INPUT (New Social Demands & Hypotheses) Ethics and Animal Protection Committee Publications Research Society (Public Funding) REVIEW (Control) GSP 1 No. 4 of 31
5 Scientific Integrity Social Competence Independency Skepticism Diligence Scientific Competence GSP 1 No. 5 of 31
6 Proper Research must be adequate efficient performed according to the rules of GSP 1 No. 6 of 31
7 Scientific Integrity and Proper Research generates TRUST GSP 1 No. 7 of 31
8 Good Scientific/Clinical Practice Requires rules and conventions, e.g. Singapore Statement on Research Integrity (world-wide) ESF European Code of Conduct (Europe) DFG Safeguarding (Germany) The policy of Hannover Medical School on the safeguarding of good scientific practice and procedural rules for dealing with scientific misconduct (MHH) GSP 1 No. 8 of 31
9 Basic Principles of GSP/GCP (1) Scientific work: State of the art Considering ethic issues and underlying laws, such as pharmaceutical and animal protection laws etc. Data management: Consistent documentation Impartial and self-critical analyses of data Long-term storage of ALL data (>= 10 years) GSP 1 No. 9 of 31
10 Basic Principles of GSP/GCP (2) Publication: Truthful and comprehensive Recognizing and acknowledging input from other contributors Correct citation of former work Adequate positioning of authors Responsibility of ALL contributing authors GSP 1 No. 10 of 31
11 Basic Principles of GSP/GCP (3) Supervision: Comprehensive introduction into basic principles of scientific work and data handling Continuous, reliable and responsible support Fairness with respect to usage of data for publications (authorship!) or for follow-up studies e.g. after leave of doctorate student GSP 1 No. 11 of 31
12 What Exactly is Data? The term data does not only refer to your primary research results but to almost every piece of information arising in context with your research project! GSP 1 No. 12 of 31
13 Data Definition Working hypotheses Material and methods applied Primary research results All correspondence in context with your research project Minutes of project related discussions and meetings Agreements on collaborations and the use of material and results GSP 1 No. 13 of 31
14 Working hypotheses What is the Old Knowledge your project is based upon? Who contributed to your ideas? If so: Why and when did you change your hypothesis? When did you inform your supervisor of the above changes? Take (and store) dated notes! GSP 1 No. 14 of 31
15 Material and Methods Are Data If feasible, store samples of the material you are using appropriately or keep detailed descriptions of the material (e.g. animal DNA, patient samples, cell lines, probes, vectors, batch numbers ) Document the methods you are applying especially any changes you might have introduced GSP 1 No. 15 of 31 Clear, durable, and legible labelling!
16 Primary Research Results refer to e.g. Electrophoresis gels, blots, photographs Scintillation counts, photometric results Sections and histochemical stainings Histograms, (mass) spectrograms, elution profiles Appropriate labelling and storage! GSP 1 No. 16 of 31
17 Correspondance, Minutes, Agreements Project-related s on experimental set up, collaborations, material exchange, use of data in general and for presentations and publications, Applications and approvals such as ethics vote, animal research approval, informed consent, Material Transfer Agreements (MTA) Minutes of meetings with supervisors and collaborators Save dates! GSP 1 No. 17 of 31
18 Generation of Data 1. Check the literature for relevant information, 2. plan and draft your experiment in advance, 3. apply state of the art techniques, 4. think of necessary controls, 5. discuss your plan with your supervisor, 6. perform your experiment strictly according to your plan (protocol!), or 7. document any change to the protocol, 8. document, analyse, discuss and store results. GSP 1 No. 18 of 31
19 Special Subject: Animal Research (1) All research involving animals must comply with the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS 123), the German Animal Welfare Act [Tierschutzgesetz (TierSchG)], the Tierschutzversuchsordnung (TierSchVerV), and the regulations effective at the MHH. GSP 1 No. 19 of 31
20 Special Subject: Animal Research (2) Scientists, who want to conduct animal research at the MHH must achieve competence in the sense of animal welfare and according to the German Animal Welfare Law (TierSchG 7) by participating in the lecture and practical course Basics in Laboratory Animal Science offered by the Laboratory Animal Sciences institute of the MHH. Upon application, the local authorities (LAVES) will provide the required Certificate of Exemption. GSP 1 No. 20 of 31
21 Special Subject: Clinical Research (1) All clinical studies (i. e. systematic measures and observations involving human subjects) must comply with the current version of the Declaration of Helsinki the German Medicinal Products Act (Gesetz über den Verkehr mit Arzneimitteln, AMG), or the German Act on Medical Products (Verordnung über Medizinprodukte, MPV), respectively, and the EU Directive on Good Clinical Practice. GSP 1 No. 21 of 31
22 Special Subject: Clinical Research (2) Approval of the Ethics Committee of the MHH is required for: Clinical investigations involving human subjects such as drug studies etc., Epidemiologic studies including personal data such as longitudinal comparison studies,, Investigations on patient material including the documentation of personal data, for tumor banks, genetic investigations or the like, Compassionate-use studies ( individueller Heilversuch ) GSP 1 No. 22 of 31
23 Special Subject: Clinical Research (3) NO Approval of the Ethics Committee of the MHH is required for: Dissertations using retrospective data (no biological specimens!) from patients files of the supervisor, exclusively, or anonymized or pseudonymized investigations on material from human subjects (CAVE: Written Informed Consent is required. The form must have been approved by the Ethics Committee previously!). GSP 1 No. 23 of 31
24 Documentation of Data Promptly, detailed, well structured, standardized, legible, and last but not least DECIPHERABLE. mons/thumb/f/f4/hexetidine_substance_pho to.jpg/1280px- Hexetidine_substance_photo.jpg Use lab language! GSP 1 No. 24 of 31
25 Remember: Your notes could/will serve as experimental instruction for others! GSP 1 No. 25 of 31
26 MHH Lab Books It is obligatory to use the MHH Lab Books. In case of data that cannot be documented in writing, such as histograms, mass specs, blots, digital data : GSP 1 No. 26 of 31 Refer to the storage location in the lab book! Document in your lab book also the batch numbers of jointly lab-wide used reagents (buffers, stock solutions ). Present your lab book to your supervisors periodically and let them sign it.
27 MHH Lab Books It is obligatory to use the MHH Lab Books. In case of data that cannot be documented in writing, such as histograms, mass specs, blots, digital data : GSP 1 No. 27 of 31 Refer to the storage location in the lab book! Document in your lab book also the batch numbers of jointly lab-wide used reagents (buffers, stock solutions ). Present your lab book to your supervisors periodically and let them sign it.
28 Safety Back up and Storage For your own safety: Take copies (paper copies or scans) of your lab book on a regular basis BUT: Get approval for copying from your supervisor first! The lab must not leave the MHH even not transiently! All data - also unpublished data! need to be stored for at least 10 years and must remain at the MHH in case the scientist moves to another institution. GSP 1 No. 28 of 31
29 Publication of Data (1) 1. Consider and discuss ALL relevant data for your analyses (incl. spikes, failures, controls ); 2. Select a suitable journal; 3. Read the instructions of the journal before starting to write the manuscript; 4. At first, draft the basic structure of the manuscript and then actually write the manuscript; 5. Use literature management software (such as RefWorks, EndNote, etc.); 6. Reflect, discuss, and get approval on your manuscript from your supervisor and all co-authors; 7. Submit your manuscript. GSP 1 No. 29 of 31
30 Publication of Data (2) If your manuscript is accepted without changes: 8. Congratulations! 9. Check and return the proofs and 10. pay the publication fee! If your manuscript is accepted with changes: 8. Congratulations! 9. Make the changes and 10. return the manuscript (on time)! GSP 1 No. 30 of 31
31 Publication of Data (3) If your manuscript can be resubmitted with changes: 8. Congratulations! 9. Make the changes and 10. resubmit the manuscript (on time)! If your manuscript is rejected: 8. Too bad, but 9. don t loose your faith in your data! 10. Revise your manuscript and try another journal GSP 1 No. 31 of 31
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