GUIDELINES FOR GOOD PRACTICE IN THE CONDUCT OF CLINICAL TRIALS IN HUMAN PARTICIPANTS IN SOUTH AFRICA
APPENDIX D
DRAFT MCC CLINICAL TRIAL EVALUATION CHECK-LIST
1.1 Previous research relating to safety and potential benefit of intervention

  • Do the results of laboratory and animal studies provide sufficient indication of the potential benefits and safety of the trial treatments in humans?

  • Has appropriate information been supplied regarding the kinetics and dynamics of the trial treatments?

  • Is this trial necessary? Do the investigators refer to a rigorous, preferably systematic review, of all previous trials that show the proposed trial would contribute further to existing knowledge?

1.2 Trial Methods

  • Are the objectives of the trial sufficient described?

  • Re the selection criteria for entry to the trial appropriate?

  • Is the source of participants sufficiently described/

  • Are the treatments well defined?

  • What method of randomisation will be used?

  • How will allocation to treatment groups be concealed?

  • Will participants, providers of care or assessors of outcome be blinded?

  • Are the outcome measures appropriate?

  • Will both benefits and harms of treatment be assessed?

  • Will both prognostic factors be considered?

  • Is there an acceptable calculation of required sample size?

  • Is the duration of post-treatment follow-up stated?

1.3 Ethical Issues

  • Will the trial be supervised by a clinically competent, medically qualified person?

  • Have the specific roles of each investigator been stated? Are these roles commensurate with the qualifications and experience of the investigators?

  • Has the renumeration to be received by the investigators and /or participants been disclosed?

  • Have all the investigation sites been listed? Do the sites have sufficient capability to carry out the study?

  • Have suitable arrangements been made to monitor protocol compliance, drug dispensing, adverse effects and data processing?

  • Have suitable arrangements been made for interim analyses and how will stopping rules be applied?

  • Is there a clear statement confirming that the applicant has satisfactorily addressed insurance and indemnity issues?

  • Do the investigation plan to obtain informed consent (in writing if possible) from study participants? Will all potential participants be adequately informed about the aims and methods of the study; the anticipated benefits, potential hazards and inconveniences associated with being in the study; and their rights to withdrawal from the study without prejudicing further treatment?

  • Have the investigators confirmed in writing that adequate reports of the research will be made publicly accessible within a reasonable period of time?

  • Has the trial protocol been approved by an appropriate ethics committee of the participating institution?

<---- Annexure C

Contents

Annexure E --->