1. Administering Informed Consent Issues for Discussion
Gerhard Fortwengel
Good Clinical Practices and
Quality Assurance SIAC
24 August 2007

2. Key questions
Does the clinical investigator, a physician, have to be personally involved in obtaining informed consent?
To what extent can the principal investigator delegate the administration of informed consent to study staff other than physicians and how should this be documented?
DIA-SIAC 24 August 2007

3. 21 CRF, section – ICH GCP 4.8.1
CRF: “...an investigator shall ... obtain the informed consent of each human subject to whom the drug is administered.“
ICH GCP: “... in obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki.“
DIA-SIAC 24 August 2007

4. Declaration of Helsinki, § 22
DoH: “... after ensuring that the subject has understood the information, the physician should then obtain the subject‘s freely-given consent ...“
DIA-SIAC 24 August 2007

5. Who should be present when the interview is conducted?
FDA Information Sheets “The person who conducts the consent interview should be knowledgeable about the study and able to answer questions. FDA does not specify who this individual should be.“
ICH GCP “... The investigator, or a person designated by the investigator...“
DIA-SIAC 24 August 2007

6. Issues to be discussed
Is direct involvement of a study physician mandatory?
Delegation of obtaining consent: definition of “... appropriately qualified study staff“ – where to be documented – delegation of authority, FDA 1572?
If the administration is a collaborative effort undertaken by a study physician and the study coordinator/study nurse, should both sign the consent form?
If not, how should involvement of study physician be recorded?
DIA-SIAC 24 August 2007

7. Good Clinical Practices and Quality Assurance SIAC
Suspected Unexpected Serious Adverse Reactions (SUSAR) Issues for Discussion
Gerhard Fortwengel
Good Clinical Practices and
Quality Assurance SIAC
24 August 2007

8. References
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (April 2006) as required by Article 18 of Directive 2001/20/EC.
DIA-SIAC 24 August 2007

9. References
Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (EudraVigilance – Clinical Trial Module) (April 2004) as required by Article 11, Article 17 and Article 18 of Directive 2001/20/EC
DIA-SIAC 24 August 2007

10. SUSAR
All suspected adverse reactions that are unexpected, serious, and suspected to be due to an investigational medical product (tested IMP, placebo, or comparator) fulfill the definition of a SUSAR. “Unexpected” can refer to either the nature or the severity of a reaction that is not consistent with any of the applicable reference product information, e.g., Investigator’s Brochure (IB) or Summary of Product Characteristics (SPC), or other applicable local labelling.
DIA-SIAC 24 August 2007

11. SUSAR
All SUSARs occurring in a clinical trial are subject to expedited reporting
The sponsor should report all the relevant safety information previously described to the concerned competent authorities and to the Ethics Committee concerned. The sponsor shall inform all investigators concerned of relevant information about SUSARs that could adversely affect the safety of subjects
DIA-SIAC 24 August 2007

12. SUSAR-Reporting
CA + ECs/IRBs Treatment codes to be broken by the sponsor before reporting a SUSAR (section of Detailed guidance on the collection ....)
Investigators When possible and appropriate, the blind should be maintained (section 5.3 of Detailed guidance on the collection ...)
DIA-SIAC 24 August 2007

13. Key question
How to handle SUSARs in countries where the investigator informs the EC/IRB?
[... e.g. and the IRB only accepts electronic submissions?]
Any feedback is much appreciated – thanks!
DIA-SIAC 24 August 2007