4. Good Research Practice.pdf

Good Research Practice Dr. Ahmed Atia Aim  To ensure that medical research is conducted to the highest scientific and ethical standards. Principles of GCP Study Study report...

Good Research Practice Dr. Ahmed Atia Aim  To ensure that medical research is conducted to the highest scientific and ethical standards. Principles of GCP Study Study report QA and Research closure control ethics Specific Protocol requirement for GCP GCP Study Procedure management manual Participant Database information and management consent form Study Data document collection file Data confidentiality Principles  Conducted according to Declaration of Helsinki.  Benefits > risks and inconvenience.  Participant rights, safety and wellbeing  most important consideration.  Scientifically sound and clearly described in the study protocol.  Comply with a protocol.  Investigators  Appropriate level of education, training and experience  Informed consent.  Data  recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.  Confidentiality of participant records  should be protected, respecting the privacy and confidentiality rules of the applicable regulatory authority.  Systems with procedures  To ensure the quality of every aspect of the study should be implemented. Research Ethics  All research undertaken MUST  comply with the authorizing Ethics Committee requirements.  Projects MUST NOT  Begin until approve in writing by Ethics Committee  Longer than authorized period  Study protocol MUST  be followed in all cases  Protocol amendment MUST  be authorized by the relevant committee(s)  Study Protocol  Study protocol describes  objective(s), design, methodology, statistical considerations and organization of a study.  background and rationale for the study.  a clear description of why the study is being undertaken, the methods to be employed and how the results will be analysed  the basis for Ethics Committee approval and up to date copies should be made available to every member of the study team  Smaller studies - provide the full study documentation.  Larger studies - incorporated into a substantially more detailed study Procedure Manual.   No research activities,  should be undertaken except in accordance with a Protocol that has been approved by an Ethics Committee. Contents of study protocol Title page Background Study design Sample size Inclusion/exclusion Recruitment Intervention Randomization Bias/confounding Data management QA/QC Data analysis Timelines Signature Principal investigator Participant Information and Consent Form  The Participant Information and Consent Form  describe the reason of the study  ensure privacy of the information collected.  written in a fashion that can be easily understood. The information in Participant Information and Consent Form  on the official hospital or university letterhead  inform the participant that the study is a research procedure and invite him/her to participate;  explain the nature and purpose of the research  explain all procedures that involve the participant,  explain the availability of alternative treatments;  explain what is required of the participant, for example a change in lifestyle, the expected number and timing of follow-up visits and any additional costs to the participant;  explain the duration of the study;  explain the possible benefits, both to the participant and to others, stressing that these benefits are by no means assured;  advise of any foreseeable risks, side effects and discomforts;  names and telephone numbers of appropriate persons to contact if necessary Study document file  The primary objective of good data handling and record keeping is to ensure that data collected on participants are accurate and unbiased with respect to the study treatment allocation. Proper document management  all paper work  To keep in an orderly fashion  To have a paper trail that can be followed throughout the study  Study may be audited at any time, even years after it has been completed.  Audits will refer to the paper trail, hence the importance of keeping organized files  Records must be kept  at least 7 years for studies not involving drugs  15 years for drug trials. Data collection  Most clinical and epidemiological research projects require a systematic gathering of information on data collection forms.  In practice, these forms may be either paper based or electronic, the latter allowing direct entry of data into a database.  All data collected for the study should be recorded directly, promptly, and accurately QA & QC Quality Assurance (QA)  This incorporates all those actions that are established to ensure that the study is performed and the data are  generated, documented, and reported in compliance with these guidelines of good clinical research practice and the applicable regulatory requirements. Quality Control (QC)  These are the operational techniques and activities undertaken within the quality assurance system to verify that the  requirements of the study-related activities have been fulfilled.  Quality control procedures must be developed and documented for all studies. This is the joint responsibility of the Principal Investigator and the Study Coordinator. Quality control  QC involves  verification of the availability of signed consent forms  verification that the protocol is being followed  verification of appropriately secure data handling  source data verification (eg checking study database against original pathology records)  review of completeness of Case Report Forms  verification of appropriate computer back up  if a study involves administration of medication, all “returns” should be kept in storage in the bottles which were provided to participants. These can be later used to verify the medication provided. Monitoring  Thisis the act of overseeing the progress of a clinical study, and of ensuring that it is conducted and recorded in accordance with the protocol, standard operating procedures, good clinical practice and the applicable regulatory requirements. Audit  An audit is a systematic and independent examination of study-related activities and documents to determine whether these activities were conducted, and the data were recorded, analysed, and accurately reported according to the protocol, standard operating procedures, good clinical practice and the applicable regulatory requirements. Study completion  On completion of data collection and during all analyses of the data, procedures must be put in place to  notify participants and their doctors of the results, if applicable  provide reports to the Ethics Committee(s) and funding bodies  arrange storage of study documentation in a systematic fashion for at least 7 years after the last publication of study results (at least 15 years for drug trials).  time required for storage of study documentation will vary from study to study.  Advice should be sought from the relevant Ethics Committee Study completion  label storage boxes clearly with the title of the study, the principal investigator, the completion date and the date on which records can be destroyed  provide information about where documentation is stored  All data management and statistical analysis programs, and packages used in the analysis should be documented Thank you!